{"id":"etoposide","rwe":[{"pmid":"41903672","year":"2026","title":"Oral solid lipid nanoparticles of etoposide enable metronomic-like therapy with reduced toxicity in MYCN-amplified neuroblastoma.","finding":"","journal":"Cancer letters","studyType":"Clinical Study"},{"pmid":"41898155","year":"2026","title":"Synergistic Antitumor Effects of Etoposide and Curcumin in Ovarian Cancer Cells.","finding":"","journal":"Biomedicines","studyType":"Clinical Study"},{"pmid":"41897459","year":"2026","title":"3,6'-Disinapoyl Sucrose from Polygalae Radix Exerts Anti-Aging Effects via Modification of Telomeres, SIRT1/p53/p21 Pathway, Oxidative Stress and Autophagy.","finding":"","journal":"Antioxidants (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41896432","year":"2026","title":"Potential of SERS and proteomics for biomarker detection in cancer cells.","finding":"","journal":"Analytical and bioanalytical chemistry","studyType":"Clinical Study"},{"pmid":"41888388","year":"2026","title":"Topoisomerase I/II inhibitors: from established drugs to next-generation therapeutics.","finding":"","journal":"Inflammopharmacology","studyType":"Clinical Study"}],"_fda":{"id":"44819553-32df-ea33-e063-6394a90a022c","set_id":"0dddbe44-b4f4-431f-9011-8a54abbd4cbf","openfda":{"nui":["N0000175609","N0000000176"],"unii":["6PLQ3CP4P3"],"route":["INTRAVENOUS"],"rxcui":["310248"],"spl_id":["44819553-32df-ea33-e063-6394a90a022c"],"brand_name":["Etoposide"],"spl_set_id":["0dddbe44-b4f4-431f-9011-8a54abbd4cbf"],"package_ndc":["68001-681-25","68001-682-26","68001-683-27"],"product_ndc":["68001-681","68001-682","68001-683"],"generic_name":["ETOPOSIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ETOPOSIDE"],"pharm_class_epc":["Topoisomerase Inhibitor [EPC]"],"pharm_class_moa":["Topoisomerase Inhibitors [MoA]"],"manufacturer_name":["BluePoint Laboratories"],"application_number":["ANDA074529"],"is_original_packager":[true]},"version":"1","warnings":["WARNINGS Patients being treated with etoposide injection must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide injection therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of etoposide injection: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm 3 or an absolute neutrophil count below 500/mm 3 is an indication to withhold further therapy until the blood counts have sufficiently recovered. Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain (see ADVERSE REACTIONS section). Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician. For parenteral administration, etoposide injection should be given only by slow intravenous infusion (usually over a 30- to 60-minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection. Pregnancy Etoposide Injection can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats. In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20 th of the human dose on a mg/m 2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7 th and 1/2 of human dose on a mg/m 2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1 mg/kg (1/16 th of human dose on a mg/m 2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10 th of human dose on a mg/m 2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight. Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus. Etoposide injection should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with etoposide injection have not been conducted in laboratory animals."],"pregnancy":["Pregnancy Etoposide Injection can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats. In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20 th of the human dose on a mg/m 2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7 th and 1/2 of human dose on a mg/m 2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1 mg/kg (1/16 th of human dose on a mg/m 2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10 th of human dose on a mg/m 2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight. Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus. Etoposide injection should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with etoposide injection have not been conducted in laboratory animals.","Pregnancy Teratogenic Effects Pregnancy \"Category D.\" (See WARNINGS section.)"],"overdosage":["OVERDOSAGE No proven antidotes have been established for etoposide injection overdosage."],"references":["REFERENCES 1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice Pittsburgh, PA: Oncology Nursing Society; 1999:32-41. 2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621. 3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA . 1985;253:1590-1591. 4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. 5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia . 1983;1:426-428. 6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin . 1983;33:258-263. 7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm . 1990;47:1033-1049. 8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.). Am J Health-SystPharm . 1996;53:1669-1685. Manufactured By: Kindos Pharmaceuticals Co., Ltd. Chengdu, China 611731 For BluePoint Laboratories Product of Italy Rev.: 09/2025"],"description":["DESCRIPTION Etoposide Injection, USP (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Etoposide Injection, USP is available for intravenous use as a sterile 20 mg per mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile, multiple dose vials. The pH of the clear, colorless to yellow solution is 3.0 to 4.0. Each mL contains: 20 mg etoposide, USP, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300 (57.5% v/v and 65.0% w/v), and 262 mg dehydrated alcohol (33.2% v/v and 26.2% w/v). The structural formula is: Structural Formula"],"precautions":["PRECAUTIONS General In all instances where the use of etoposide injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician. Reinstitution of etoposide injection therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity. Patients with low serum albumin may be at an increased risk for etoposide associated toxicities. Drug Interactions High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone. Laboratory Tests Periodic complete blood counts should be done during the course of etoposide injection treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of etoposide injection. Renal Impairment In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance: Measured Creatinine Clearance >50 mL/min 15 to 50 mL/min etoposide 100% of dose 75% of dose Subsequent etoposide injection dosing should be based on patient tolerance and clinical effect. Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients. Carcinogenesis, Mutagenesis, Impairment of Fertility (see WARNINGS section) Etoposide has been shown to be mutagenic in Ames assay. Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of etoposide injection on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected. Irreversible testicular atrophy was present in rats treated with etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16 th of the human dose on a mg/m 2 basis). Pregnancy Teratogenic Effects Pregnancy \"Category D.\" (See WARNINGS section.) Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from etoposide injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Etoposide injection contains polysorbate 80. In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80. Anaphylactic reactions have been reported in pediatric patients (see WARNINGS section). Geriatric Use Clinical studies of etoposide injection for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Of more than 600 patients in four clinical studies in the NDA databases who received etoposide injection or etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one third were older than 65 years. When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset. In the one study (etoposide in combination with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or cyclophosphamide, vincristine, and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the etoposide regimen compared with the control regimens. No differences in myelosuppression were seen between elderly and younger patients in these studies except for an increased frequency of WHO Grade III or IV leukopenia among elderly patients in a study of etoposide phosphate or etoposide in combination with cisplatin. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated BUN levels than younger patients. In five single-agent studies of etoposide phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more. WHO Grade III or IV leukopenia, granulocytopenia, and asthenia were more frequent among elderly patients. Postmarketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of etoposide, including myelosuppression, gastrointestinal effects, infectious complications, and alopecia. Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant. Etoposide and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS , Renal Impairment for recommended dosing adjustments in patients with renal impairment)."],"how_supplied":["HOW SUPPLIED Etoposide Injection, USP, 20 mg per mL is supplied as follows: NDC Etoposide Injection, USP (20 mg per mL) Package Factor 68001- 681 -25 100 mg per 5 mL Multi-Dose Vial 1 vial per carton 68001- 682 -26 500 mg per 25 mL Multi-Dose Vial 1 vial per carton 68001- 683 -27 1 gram per 50 mL Multi-Dose Vial 1 vial per carton All are available individually packaged. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DO NOT FREEZE. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"boxed_warning":["WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur."],"geriatric_use":["Geriatric Use Clinical studies of etoposide injection for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Of more than 600 patients in four clinical studies in the NDA databases who received etoposide injection or etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one third were older than 65 years. When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset. In the one study (etoposide in combination with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or cyclophosphamide, vincristine, and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the etoposide regimen compared with the control regimens. No differences in myelosuppression were seen between elderly and younger patients in these studies except for an increased frequency of WHO Grade III or IV leukopenia among elderly patients in a study of etoposide phosphate or etoposide in combination with cisplatin. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated BUN levels than younger patients. In five single-agent studies of etoposide phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more. WHO Grade III or IV leukopenia, granulocytopenia, and asthenia were more frequent among elderly patients. Postmarketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of etoposide, including myelosuppression, gastrointestinal effects, infectious complications, and alopecia. Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant. Etoposide and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS , Renal Impairment for recommended dosing adjustments in patients with renal impairment)."],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established. Etoposide injection contains polysorbate 80. In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80. Anaphylactic reactions have been reported in pediatric patients (see WARNINGS section)."],"effective_time":"20251201","nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from etoposide injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother."],"laboratory_tests":["Laboratory Tests Periodic complete blood counts should be done during the course of etoposide injection treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of etoposide injection."],"pharmacokinetics":["Pharmacokinetics On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m 2 and, like the terminal elimination half-life, are independent of dose over a range 100 to 600 mg/m 2 . Over the same dose range, the areas under the plasma concentration vs time curves (AUC) and the maximum plasma concentration (C max ) values increase linearly with dose. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m 2 for 4 to 5 days. The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m 2 . Etoposide enters the CSF poorly. Although it is detectable in CSF and intracerebral tumors, the concentrations are lower than in extracerebral tumors and in plasma. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. In vitro , etoposide is highly protein bound (97%) to human plasma proteins. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. In a study determining the effect of other therapeutic agents on the in vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved in vivo . Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide (see PRECAUTIONS section). After intravenous administration of 14 C-etoposide (100 to 124 mg/m 2 ), mean recovery of radioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours. In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. The mean renal clearance of etoposide is 7 to 10 mL/min/m 2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m 2 . Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. The effect of renal disease on plasma etoposide clearance is not known. Biliary excretion of unchanged drug and/or metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. The hydroxy acid metabolite [4'-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene-β-D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. It is also present in human plasma, presumably as the trans isomer. Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of 14 C-etoposide. In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol. After either intravenous infusion or oral capsule administration, the C max and AUC values exhibit marked intra- and inter-subject variability. In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state (see PRECAUTIONS section). Use of cisplatin therapy is associated with reduced total body clearance. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children. Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant."],"adverse_reactions":["ADVERSE REACTIONS The following data on adverse reactions are based on both oral and intravenous administration of etoposide injection as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic Toxicity Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported. The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with etoposide injection in association with other antineoplastic agents (see WARNINGS section). Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion. Hypotension Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. It has not been associated with cardiac toxicity or electrocardiographic changes. No delayed hypotension has been noted. To prevent this rare occurrence, it is recommended that etoposide injection be administered by slow intravenous infusion over a 30- to 60-minute period. If hypotension occurs, it usually responds to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. When restarting the infusion, a slower administration rate should be used. Allergic Reactions Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous etoposide injection and in less than 1% of the patients treated with the oral capsules. These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the infusion. Anaphylactic-like reactions have occurred during the initial infusion of etoposide injection. Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely. Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported. Alopecia Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients. Other Toxicities The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis. Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with etoposide injection. Metabolic acidosis has also been reported in patients receiving higher doses. Reports of extravasation with swelling have been received postmarketing. Rarely extravasation has been associated with necrosis and venous induration. The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when etoposide injection was used either orally or by injection as a single agent. ADVERSE DRUG EFFECT PERCENT RANGE OF REPORTED INCIDENCE Hematologic toxicity Leukopenia (less than 1,000 WBC/mm 3 ) 3 to 17 Leukopenia (less than 4,000 WBC/mm 3 ) 60 to 91 Thrombocytopenia (less than 50,000 platelets/mm 3 ) 1 to 20 Thrombocytopenia (less than 100,000 platelets/mm 3 ) 22 to 41 Anemia 0 to 33 Gastrointestinal toxicity Nausea and vomiting 31 to 43 Abdominal pain 0 to 2 Anorexia 10 to 13 Diarrhea 1 to 13 Stomatitis 1 to 6 Hepatic 0 to 3 Alopecia 8 to 66 Peripheral neurotoxicity 1 to 2 Hypotension 1 to 2 Allergic reaction 1 to 2 To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["CONTRAINDICATIONS Etoposide injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation."],"drug_interactions":["Drug Interactions High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone."],"precautions_table":["<table width=\"100%\"><col width=\"47%\"/><col width=\"23%\"/><col width=\"28%\"/><tbody><tr styleCode=\"Toprule\"><td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>Measured Creatinine Clearance</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>&gt;50 mL/min</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>15 to 50 mL/min</paragraph></td></tr><tr styleCode=\"Botrule\"><td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>etoposide</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>100% of dose</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>75% of dose</paragraph></td></tr></tbody></table>"],"how_supplied_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"21%\"/><col width=\"42%\"/><col width=\"35%\"/><thead><tr><th align=\"left\" valign=\"top\"><content styleCode=\"bold\">NDC</content></th><th align=\"left\" valign=\"top\"><content styleCode=\"bold\">Etoposide Injection, USP (20 mg per mL)</content></th><th align=\"left\" valign=\"top\"><content styleCode=\"bold\">Package Factor</content></th></tr></thead><tbody><tr><td valign=\"top\"><paragraph>68001- <content styleCode=\"bold\">681</content>-25 </paragraph></td><td valign=\"top\"><paragraph>100 mg per 5 mL Multi-Dose Vial</paragraph></td><td valign=\"top\"><paragraph>1 vial per carton</paragraph></td></tr><tr><td valign=\"top\"><paragraph>68001- <content styleCode=\"bold\">682</content>-26 </paragraph></td><td valign=\"top\"><paragraph>500 mg per 25 mL Multi-Dose Vial</paragraph></td><td valign=\"top\"><paragraph>1 vial per carton</paragraph></td></tr><tr><td valign=\"top\"><paragraph>68001- <content styleCode=\"bold\">683</content>-27 </paragraph></td><td valign=\"top\"><paragraph>1 gram per 50 mL Multi-Dose Vial</paragraph></td><td valign=\"top\"><paragraph>1 vial per carton</paragraph></td></tr></tbody></table>"],"general_precautions":["General In all instances where the use of etoposide injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician. Reinstitution of etoposide injection therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity. Patients with low serum albumin may be at an increased risk for etoposide associated toxicities."],"teratogenic_effects":["Teratogenic Effects Pregnancy \"Category D.\" (See WARNINGS section.)"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Etoposide Injection has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G 2 portion of the cell cycle in mammalian cells. Two different dose-dependent responses are seen. At high concentrations (10 mcg/mL or more), lysis of cells entering mitosis is observed. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. It does not interfere with microtubular assembly. The predominant macromolecular effect of etoposide appears to be the induction of DNA strand breaks by an interaction with DNA topoisomerase II or the formation of free radicals. Pharmacokinetics On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m 2 and, like the terminal elimination half-life, are independent of dose over a range 100 to 600 mg/m 2 . Over the same dose range, the areas under the plasma concentration vs time curves (AUC) and the maximum plasma concentration (C max ) values increase linearly with dose. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m 2 for 4 to 5 days. The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m 2 . Etoposide enters the CSF poorly. Although it is detectable in CSF and intracerebral tumors, the concentrations are lower than in extracerebral tumors and in plasma. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. In vitro , etoposide is highly protein bound (97%) to human plasma proteins. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. In a study determining the effect of other therapeutic agents on the in vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved in vivo . Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide (see PRECAUTIONS section). After intravenous administration of 14 C-etoposide (100 to 124 mg/m 2 ), mean recovery of radioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours. In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. The mean renal clearance of etoposide is 7 to 10 mL/min/m 2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m 2 . Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. The effect of renal disease on plasma etoposide clearance is not known. Biliary excretion of unchanged drug and/or metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. The hydroxy acid metabolite [4'-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene-β-D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. It is also present in human plasma, presumably as the trans isomer. Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of 14 C-etoposide. In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol. After either intravenous infusion or oral capsule administration, the C max and AUC values exhibit marked intra- and inter-subject variability. In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state (see PRECAUTIONS section). Use of cisplatin therapy is associated with reduced total body clearance. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children. Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant."],"indications_and_usage":["INDICATIONS AND USAGE Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small Cell Lung Cancer Etoposide Injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer."],"adverse_reactions_table":["<table width=\"100%\"><col width=\"54%\"/><col width=\"44%\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">ADVERSE DRUG EFFECT</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">PERCENT RANGE OF REPORTED INCIDENCE</content></paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Hematologic toxicity</content></paragraph></td><td styleCode=\"Rrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Leukopenia (less than 1,000 WBC/mm <sup>3</sup>) </paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>3 to 17</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Leukopenia (less than 4,000 WBC/mm <sup>3</sup>) </paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>60 to 91</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Thrombocytopenia (less than 50,000 platelets/mm <sup>3</sup>) </paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>1 to 20</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Thrombocytopenia (less than 100,000</paragraph><paragraph>platelets/mm <sup>3</sup>) </paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>22 to 41</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph> Anemia</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0 to 33</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Gastrointestinal toxicity</content></paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Nausea and vomiting</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>31 to 43</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Abdominal pain</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>0 to 2</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Anorexia</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>10 to 13</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Diarrhea</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>1 to 13</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Stomatitis</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>1 to 6</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph> Hepatic</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>0 to 3</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph>Alopecia</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>8 to 66</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph>Peripheral neurotoxicity</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>1 to 2</paragraph></td></tr><tr><td styleCode=\"Lrule \" valign=\"top\"><paragraph>Hypotension</paragraph></td><td align=\"center\" styleCode=\"Rrule \" valign=\"top\"><paragraph>1 to 2</paragraph></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>Allergic reaction</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1 to 2</paragraph></td></tr></tbody></table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with undiluted etoposide injection. Etoposide Injection The usual dose of etoposide injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m 2 /day on days 1 through 5 to 100 mg/m 2 /day on days 1, 3, and 5. In small cell lung cancer, the etoposide injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m 2 /day for 4 days to 50 mg/m 2 /day for 5 days. For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section. Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity. The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve. Administration Precautions As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of etoposide injection. Skin reactions associated with accidental exposure to etoposide injection may occur. The use of gloves is recommended. If etoposide injection solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. Preparation for Intravenous Administration Etoposide injection must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the etoposide injection solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. Etoposide injection should not be given by rapid intravenous injection. Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit. Stability Unopened vials of etoposide injection are stable until the date indicated on the package at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate."],"spl_product_data_elements":["Etoposide Etoposide ANHYDROUS CITRIC ACID POLYSORBATE 80 POLYETHYLENE GLYCOL 300 ALCOHOL ETOPOSIDE ETOPOSIDE Etoposide Etoposide ANHYDROUS CITRIC ACID POLYSORBATE 80 POLYETHYLENE GLYCOL 300 ALCOHOL ETOPOSIDE ETOPOSIDE Etoposide Etoposide ANHYDROUS CITRIC ACID POLYSORBATE 80 POLYETHYLENE GLYCOL 300 ALCOHOL ETOPOSIDE ETOPOSIDE"],"package_label_principal_display_panel":["PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Etoposide Injection, USP 100 mg per 5 mL Vial Label NDC 68001-681-25 Rx Only Etoposide Injection, USP 100 mg per 5 mL (20 mg per mL) Must Be Diluted Before Intravenous Infusion 5 mL Multiple-Dose Vial Etoposide 100mg/5ml label PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Etoposide Injection, USP 100 mg per 5 mL Carton NDC 68001-681-25 Rx Only Etoposide Injection, USP 100 mg per 5 mL (20 mg per mL) Warning: Cytotoxic Agent Must Be Diluted Before Intravenous Infusion 1 x 5 mL Multiple-Dose Vial Etoposide 100mg/5ml carton","PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Etoposide Injection, USP 500 mg per 25 mL Vial Label NDC 68001-682-26 Rx Only Etoposide Injection, USP 500 mg per 25 mL (20 mg per mL) Must Be Diluted Before Intravenous Infusion 25 mL Multiple-Dose Vial Etoposide 500mg/20ml label PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Etoposide Injection, USP 500 mg per 25 mL Carton NDC 68001-682-26 Rx Only Etoposide Injection, USP 500 mg per 25 mL (20 mg per mL) Warning: Cytotoxic Agent Must Be Diluted Before Intravenous Infusion 1 x 25 mL Multiple-Dose Vial Etoposide 500mg/25ml carton","PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Etoposide Injection, USP 1 gram per 50 mL Vial Label NDC 68001-683-27 Rx Only Etoposide Injection, USP 1 gram per 50 mL (20 mg per mL) Must Be Diluted Before Intravenous Infusion 50 mL Multiple-Dose Vial Etoposide 1gm/50ml label PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Etoposide Injection, USP 1 gram per 50 mL Carton Label NDC 68001-683-27 Rx Only Etoposide Injection, USP 1 gram per 50 mL (20 mg per mL) Warning: Cytotoxic Agent Must Be Diluted Before Intravenous Infusion 1 x 50 mL Multiple-Dose Vial Etoposide 1gm/50ml label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility (see WARNINGS section) Etoposide has been shown to be mutagenic in Ames assay. Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of etoposide injection on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected. Irreversible testicular atrophy was present in rats treated with etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16 th of the human dose on a mg/m 2 basis)."]},"tags":[{"label":"Topoisomerase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"DNA topoisomerase 2-alpha","category":"target"},{"label":"TOP2A","category":"gene"},{"label":"TOP2B","category":"gene"},{"label":"ABCB1","category":"gene"},{"label":"L01CB01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Capsule","category":"form"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Malignant tumor of testis","category":"indication"},{"label":"Small cell carcinoma of lung","category":"indication"},{"label":"Treatment prior to tumor-specific T-cell infusion therapy","category":"indication"},{"label":"Bristol-Myers Squibb K.K.","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Phytogenic","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Topoisomerase II Inhibitors","category":"pharmacology"},{"label":"Topoisomerase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur."],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"7835 reports"},{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"7351 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"4873 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"4554 reports"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"4422 reports"},{"date":"","signal":"THROMBOCYTOPENIA","source":"FDA FAERS","actionTaken":"3947 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"3303 reports"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"3225 reports"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"2979 reports"},{"date":"","signal":"SEPSIS","source":"FDA FAERS","actionTaken":"2907 reports"}],"commonSideEffects":[{"effect":"Alopecia","drugRate":"66%","severity":"serious","_validated":true},{"effect":"Anemia","drugRate":"≥33%","severity":"serious","_validated":true},{"effect":"Leukopenia (less than 4,000 WBC/mm3)","drugRate":"60-91%","severity":"serious","_validated":true},{"effect":"Thrombocytopenia (less than 100,000 platelets/mm3)","drugRate":"22-41%","severity":"serious","_validated":true},{"effect":"Thrombocytopenia (less than 50,000 platelets/mm3)","drugRate":"≥20%","severity":"serious","_validated":true},{"effect":"Leukopenia (less than 1,000 WBC/mm3)","drugRate":"≥17%","severity":"serious","_validated":true},{"effect":"Nausea and vomiting","drugRate":"31-43%","severity":"serious","_validated":true},{"effect":"Anorexia","drugRate":"10-13%","severity":"common","_validated":true},{"effect":"Abdominal pain","drugRate":"10-13%","severity":"common","_validated":true},{"effect":"Diarrhea","drugRate":"≥13%","severity":"common","_validated":true},{"effect":"Stomatitis","drugRate":"≥10%","severity":"common","_validated":true},{"effect":"Hepatic","drugRate":"≥10%","severity":"common","_validated":true},{"effect":"Hypotension","drugRate":"1-2%","severity":"mild","_validated":true},{"effect":"Allergic reaction","drugRate":"0.7-2%","severity":"mild","_validated":true},{"effect":"Fever","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Fatigue","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Malaise","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Somnolence","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Asthenia","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Constipation","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Dysphagia","drugRate":"≥5%","severity":"mild","_validated":true},{"effect":"Rash","drugRate":"<1%","severity":"mild","_validated":true},{"effect":"Urticaria","drugRate":"<1%","severity":"mild","_validated":true},{"effect":"Pruritus","drugRate":"<1%","severity":"mild","_validated":true}],"contraindications":["Acute hemorrhage","Acute infectious disease","Anemia","Bone marrow depression","Breastfeeding (mother)","Drug-induced hepatitis","Fibrosis of lung","Hypoalbuminemia","Impaired renal function disorder","Interstitial pneumonia","Leukopenia","Metabolic acidosis","Neutropenic disorder","Pregnancy, function","Thrombocytopenic disorder"],"specialPopulations":{"Pregnancy":"Toposar can cause fetal harm when administered to pregnant woman. Etoposide has been shown to be teratogenic in mice and rats. In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th of the human dose on mg/m2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7th and 1/2 of human dose on mg/m2 basis) resulted in 90","Geriatric use":"Of more than 600 patients in four clinical studies in the NDA databases who received etoposide or etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one-third were older than 65 years. When advanced age was determined to be prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset. In the one study (etoposide in combination with","Paediatric use":"Safety and effectiveness in pediatric patients have not been established.Toposar contains polysorbate 80. In premature infants, life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin product containing polysorbate 80. Anaphylactic reactions have been reported in pediatric patients (see WARNINGS section)."}},"trials":[],"aliases":[],"company":"Bristol-Myers Squibb K.K.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=etoposide","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:52:41.104271+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Etoposide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:52:49.598647+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:52:48.266038+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:52:39.744665+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=etoposide","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:52:49.025776+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:38.016287+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:38.016325+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNINGS Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:38.016339+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:52:50.556349+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA topoisomerase II alpha inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:49.598527+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200645/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:49.491521+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA074529","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:38.016348+00:00"}},"allNames":"vepesid","offLabel":[],"synonyms":["etoposide","etosid","fytosid","toposar","zuyeyidal","VP-16"],"timeline":[{"date":"1983-11-10","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1995-08-30","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 4 manufacturers approved"},{"date":"2019-03-26","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Bristol-Myers Squibb K.K.)"},{"date":"2026-02-13","type":"positive","source":"FDA Orange Book","milestone":"Avopef approved — 100MG/5ML (20MG/ML)"}],"aiSummary":"Vepesid (etoposide) is a topoisomerase inhibitor small molecule originally developed by Bristol-Myers Squibb K.K. and currently owned by Onesource Specialty. It targets DNA topoisomerase 2-alpha, an enzyme involved in DNA replication and repair. Vepesid is FDA-approved for treating malignant tumors of the testis, small cell carcinoma of the lung, and as a treatment prior to tumor-specific T-cell infusion therapy. The drug is off-patent, with 14 generic manufacturers available. Key safety considerations include its potential for myelosuppression and hepatotoxicity.","brandName":"Vepesid","ecosystem":[{"indication":"Malignant tumor of testis","otherDrugs":[{"name":"dactinomycin","slug":"dactinomycin","company":"Recordati Rare"},{"name":"etoposide phosphate","slug":"etoposide-phosphate","company":"Bristol Myers Squibb"},{"name":"plicamycin","slug":"plicamycin","company":""},{"name":"vinblastine","slug":"vinblastine","company":""}],"globalPrevalence":null},{"indication":"Small cell carcinoma of lung","otherDrugs":[{"name":"doxorubicin","slug":"doxorubicin","company":""},{"name":"durvalumab","slug":"durvalumab","company":"Astrazeneca Uk Ltd"},{"name":"etoposide phosphate","slug":"etoposide-phosphate","company":"Bristol Myers Squibb"},{"name":"lurbinectedin","slug":"lurbinectedin","company":"Jazz"}],"globalPrevalence":null},{"indication":"Treatment prior to tumor-specific T-cell infusion therapy","otherDrugs":[{"name":"bendamustine","slug":"bendamustine","company":"Cephalon"},{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"}],"globalPrevalence":null}],"mechanism":{"target":"DNA topoisomerase 2-alpha","novelty":"Follow-on","targets":[{"gene":"TOP2A","source":"DrugCentral","target":"DNA topoisomerase 2-alpha","protein":"DNA topoisomerase 2-alpha"},{"gene":"TOP2B","source":"DrugCentral","target":"DNA topoisomerase 2-beta","protein":"DNA topoisomerase 2-beta"},{"gene":"ABCB1","source":"DrugCentral","target":"Multidrug resistance protein 1","protein":"Multidrug resistance protein 1"},{"gene":"ABCC2","source":"DrugCentral","target":"Canalicular multispecific organic anion transporter 1","protein":"Canalicular multispecific organic anion transporter 1"},{"gene":"ABCG2","source":"DrugCentral","target":"ATP-binding cassette sub-family G member 2","protein":"ATP-binding cassette sub-family G member 2"},{"gene":"ABCC3","source":"DrugCentral","target":"Canalicular multispecific organic anion transporter 2","protein":"Canalicular multispecific organic anion transporter 2"},{"gene":"ABCC1","source":"DrugCentral","target":"Multidrug resistance-associated protein 1","protein":"Multidrug resistance-associated protein 1"},{"gene":"ABCC6","source":"DrugCentral","target":"Multidrug resistance-associated protein 6","protein":"Multidrug resistance-associated protein 6"},{"gene":"NR1I2","source":"DrugCentral","target":"Nuclear receptor subfamily 1 group I member 2","protein":"Nuclear receptor subfamily 1 group I member 2"}],"moaClass":"Topoisomerase Inhibitors","modality":"Small Molecule","drugClass":"Topoisomerase Inhibitor [EPC]","explanation":"","oneSentence":"","technicalDetail":"Vepesid (etoposide) acts as a competitive inhibitor of DNA topoisomerase 2-alpha, binding to the enzyme's active site and preventing the enzyme from catalyzing the religation of DNA strand breaks, thereby inducing DNA damage and triggering apoptosis in cancer cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Etoposide","title":"Etoposide","extract":"Etoposide, sold under the brand name Vepesid among others, is a chemotherapy medication used for the treatments of a number of types of cancer including testicular cancer, lung cancer, lymphoma, leukemia, neuroblastoma, and ovarian cancer. It is also used for hemophagocytic lymphohistiocytosis. It is used by mouth or injection into a vein.","wiki_history":"==History==\nEtoposide was first synthesized in 1966 and U.S. Food and Drug Administration approval was granted in 1983.\n\nThe nickname VP-16 likely comes from a compounding of the last name of one of the chemists who performed early work on the drug (von Wartburg) and podophyllotoxin. Another scientist who was integral in the development of podophyllotoxin-based chemotherapeutics was the medical pharmacologist Hartmann F. Stähelin.\n"},"commercial":{"launchDate":"1983","_launchSource":"DrugCentral (FDA 1983-11-10, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1112","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=etoposide","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=etoposide","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Etoposide","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:30:26.912695","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:52:54.658317+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"teniposide","drugSlug":"teniposide","fdaApproval":"1992-07-14","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"etoposide","indications":{"approved":[{"name":"Malignant tumor of testis","source":"DrugCentral","snomedId":363449006,"regulator":"FDA"},{"name":"Small cell carcinoma of lung","source":"DrugCentral","snomedId":254632001,"regulator":"FDA"},{"name":"Treatment prior to tumor-specific T-cell infusion therapy","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[{"name":"Acute myeloid leukemia, disease","source":"DrugCentral","drugName":"etoposide","evidenceCount":1729,"evidenceLevel":"strong"},{"name":"Allogeneic bone marrow transplantation","source":"DrugCentral","drugName":"etoposide","evidenceCount":427,"evidenceLevel":"strong"},{"name":"Burkitt's lymphoma","source":"DrugCentral","drugName":"etoposide","evidenceCount":240,"evidenceLevel":"strong"},{"name":"Diffuse non-Hodgkin's lymphoma, large cell","source":"DrugCentral","drugName":"etoposide","evidenceCount":908,"evidenceLevel":"strong"},{"name":"Ewing's sarcoma","source":"DrugCentral","drugName":"etoposide","evidenceCount":423,"evidenceLevel":"strong"},{"name":"Hodgkin's disease","source":"DrugCentral","drugName":"etoposide","evidenceCount":1896,"evidenceLevel":"strong"},{"name":"Kaposi's sarcoma","source":"DrugCentral","drugName":"etoposide","evidenceCount":94,"evidenceLevel":"strong"},{"name":"Malignant tumor of ovary","source":"DrugCentral","drugName":"etoposide","evidenceCount":1043,"evidenceLevel":"strong"},{"name":"Multiple myeloma","source":"DrugCentral","drugName":"etoposide","evidenceCount":432,"evidenceLevel":"strong"},{"name":"Neuroblastoma","source":"DrugCentral","drugName":"etoposide","evidenceCount":647,"evidenceLevel":"strong"},{"name":"Neuroendocrine Prostate Carcinoma","source":"DrugCentral","drugName":"etoposide"},{"name":"Non-small cell lung cancer","source":"DrugCentral","drugName":"etoposide"},{"name":"Osteosarcoma of bone","source":"DrugCentral","drugName":"etoposide"},{"name":"Ovarian Germ Cell Tumor Carcinoma","source":"DrugCentral","drugName":"etoposide"},{"name":"Progressive Diffuse Large B-Cell Lymphoma","source":"DrugCentral","drugName":"etoposide"},{"name":"Testicular Germ Cell Tumor","source":"DrugCentral","drugName":"etoposide"}],"pipeline":[]},"currentOwner":"Onesource Specialty","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"teniposide","brandName":"teniposide","genericName":"teniposide","approvalYear":"1992","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04759586","phase":"PHASE3","title":"Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-10-05","conditions":["Primary Mediastinal Large B-Cell Lymphoma"],"enrollment":244,"completionDate":"2026-12-31"},{"nctId":"NCT02306161","phase":"PHASE3","title":"Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-12-12","conditions":["Metastatic Ewing Sarcoma","Metastatic Malignant Neoplasm in the Bone","Metastatic Malignant Neoplasm in the Bone Marrow","Metastatic Malignant Neoplasm in the Lung","Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone","Peripheral Primitive Neuroectodermal Tumor of Soft Tissues"],"enrollment":312,"completionDate":"2026-09-17"},{"nctId":"NCT07155174","phase":"PHASE2","title":"A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-11-25","conditions":["Small Cell Lung Cancer"],"enrollment":180,"completionDate":"2031-09"},{"nctId":"NCT02436707","phase":"PHASE2","title":"Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Canadian Cancer Trials Group","startDate":"2015-10-27","conditions":["Lymphoma"],"enrollment":129,"completionDate":"2026-12-31"},{"nctId":"NCT07055581","phase":"PHASE2","title":"Durvalumab as Consolidation for Patients LS-SCLC","status":"RECRUITING","sponsor":"Qian Chu","startDate":"2026-02-24","conditions":["Small Cell Lung Cancer Limited Stage"],"enrollment":100,"completionDate":"2029-07-31"},{"nctId":"NCT00092222","phase":"PHASE2","title":"Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2004-10-28","conditions":["Lymphoproliferative Disorder","HHV-8","Malignancy","HIV"],"enrollment":75,"completionDate":"2026-10-01"},{"nctId":"NCT06172296","phase":"PHASE3","title":"Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-04-19","conditions":["Ganglioneuroblastoma, Nodular","Neuroblastoma"],"enrollment":478,"completionDate":"2029-12-31"},{"nctId":"NCT04301076","phase":"PHASE1","title":"Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (\"EPOCH\") for Adult T-Cell Leukemia-Lymphoma (ATLL)","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2021-08-31","conditions":["Acute Adult T-Cell Leukemia/Lymphoma","Adult T-Cell Leukemia/Lymphoma","Chronic Adult T-Cell Leukemia/Lymphoma","HTLV-1 Infection"],"enrollment":30,"completionDate":"2027-06-30"},{"nctId":"NCT05058651","phase":"PHASE2,PHASE3","title":"Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-06-28","conditions":["Advanced Extrapulmonary Neuroendocrine Carcinoma","Metastatic Extrapulmonary Neuroendocrine Carcinoma","Recurrent Extrapulmonary Neuroendocrine Carcinoma","Unresectable Extrapulmonary Neuroendocrine Carcinoma"],"enrollment":189,"completionDate":"2028-10-01"},{"nctId":"NCT02166463","phase":"PHASE3","title":"Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2015-03-19","conditions":["Ann Arbor Stage IIB Hodgkin Lymphoma","Ann Arbor Stage IIIB Hodgkin Lymphoma","Ann Arbor Stage IVA Hodgkin Lymphoma","Ann Arbor Stage IVB Hodgkin Lymphoma","Childhood Hodgkin Lymphoma","Classic Hodgkin Lymphoma"],"enrollment":600,"completionDate":"2026-10-03"},{"nctId":"NCT02443077","phase":"PHASE3","title":"Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2016-10-12","conditions":["Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type"],"enrollment":94,"completionDate":"2026-12-23"},{"nctId":"NCT00792948","phase":"PHASE2","title":"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2009-09-01","conditions":["Acute Lymphoblastic Leukemia","Adult B Acute Lymphoblastic Leukemia","Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Adult L1 Acute Lymphoblastic Leukemia","Adult L2 Acute Lymphoblastic Leukemia","Adult T Acute Lymphoblastic Leukemia","Recurrent Adult Acute Lymphoblastic Leukemia"],"enrollment":97,"completionDate":"2027-01-06"},{"nctId":"NCT07498959","phase":"NA","title":"Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer","status":"RECRUITING","sponsor":"Sahlgrenska University Hospital","startDate":"2026-03-19","conditions":["Testicular Cancer","Seminoma","Quality of Life","De-escalation","RPLND"],"enrollment":160,"completionDate":"2032-03-25"},{"nctId":"NCT03983824","phase":"PHASE1","title":"Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-05-05","conditions":["Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia"],"enrollment":48,"completionDate":"2026-06-30"},{"nctId":"NCT03984448","phase":"PHASE2,PHASE3","title":"Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-10-22","conditions":["Diffuse Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Double-Expressor Lymphoma","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Neoplastic Cells With Double Expression of MYC and BCL2 Proteins Present","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma"],"enrollment":363,"completionDate":"2028-04-01"},{"nctId":"NCT05675410","phase":"PHASE3","title":"A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-05-11","conditions":["Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8"],"enrollment":1875,"completionDate":"2031-04-28"},{"nctId":"NCT07497438","phase":"PHASE3","title":"Comparison of Two Etoposide Initiation Strategies for Severe Hemophagocytic Lymphohistiocytosis","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2026-04","conditions":["Hemophagocytic Lymphohistiocytosis"],"enrollment":176,"completionDate":"2030-02"},{"nctId":"NCT06406465","phase":"PHASE2","title":"A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-04-01","conditions":["Carcinoma, Neuroendocrine","Tumor, Neuroendocrine","Tumors, Neuroendocrine","Neuroendocrine; Carcinoma","Small Cell; Receptors"],"enrollment":60,"completionDate":"2028-07-30"},{"nctId":"NCT04092283","phase":"PHASE3","title":"Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-04-29","conditions":["Recurrent Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Unresectable Lung Non-Small Cell Carcinoma"],"enrollment":660,"completionDate":"2028-12-31"},{"nctId":"NCT07497165","phase":"","title":"Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma","status":"RECRUITING","sponsor":"Shanxi Bethune Hospital","startDate":"2025-11-01","conditions":["Relapsed/Refractory Multiple Myeloma (RRMM)","Multiple Myeloma"],"enrollment":48,"completionDate":"2027-06-30"},{"nctId":"NCT05019716","phase":"PHASE1,PHASE2","title":"Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-07-13","conditions":["Advanced NUT Carcinoma","Metastatic NUT Carcinoma","Unresectable NUT Carcinoma"],"enrollment":36,"completionDate":"2026-06-30"},{"nctId":"NCT03811002","phase":"PHASE3","title":"Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-26","conditions":["Limited Stage Lung Small Cell Carcinoma","Stage I Lung Cancer AJCC v8","Stage II Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8"],"enrollment":544,"completionDate":"2029-02-21"},{"nctId":"NCT00576979","phase":"PHASE1,PHASE2","title":"Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"City of Hope Medical Center","startDate":"2008-03-04","conditions":["Leukemia"],"enrollment":51,"completionDate":"2026-01-07"},{"nctId":"NCT06314334","phase":"PHASE2","title":"Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma","status":"RECRUITING","sponsor":"Fudan University","startDate":"2024-03-04","conditions":["Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type"],"enrollment":210,"completionDate":"2028-12-30"},{"nctId":"NCT07224100","phase":"PHASE2","title":"Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma","status":"RECRUITING","sponsor":"University of Washington","startDate":"2026-04-15","conditions":["B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Lymphoblastic Leukemia/Lymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1","Lymphoblastic Lymphoma"],"enrollment":33,"completionDate":"2028-07-31"},{"nctId":"NCT05903092","phase":"PHASE2","title":"MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer","status":"SUSPENDED","sponsor":"Hirva Mamdani","startDate":"2023-09-26","conditions":["Small Cell Lung Cancer","SCLC","Extensive Stage Small Cell Lung Cancer","Limited Stage Small-Cell Lung Cancer"],"enrollment":84,"completionDate":"2028-01-03"},{"nctId":"NCT06897579","phase":"PHASE2","title":"Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2025-04-07","conditions":["Extensive Stage Small Cell Lung Cancer"],"enrollment":134,"completionDate":"2027-04"},{"nctId":"NCT06528691","phase":"PHASE2","title":"Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors","status":"RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2026-04","conditions":["High Grade Glioma","CNS Tumor"],"enrollment":52,"completionDate":"2032-11"},{"nctId":"NCT07227597","phase":"PHASE1,PHASE2","title":"A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2026-01-29","conditions":["Small Cell Lung Cancer Extensive Stage"],"enrollment":170,"completionDate":"2030-12-30"},{"nctId":"NCT03420963","phase":"PHASE1","title":"Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2018-08-31","conditions":["Recurrent Cutaneous Melanoma","Recurrent Lip and Oral Cavity Carcinoma","Recurrent Malignant Endocrine Neoplasm","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Male Reproductive System Neoplasm","Recurrent Malignant Mesothelioma","Recurrent Malignant Neoplasm of Multiple Primary Sites","Recurrent Malignant Oral Neoplasm","Recurrent Malignant Pharyngeal Neoplasm","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Soft Tissue Neoplasm","Recurrent Malignant Solid Neoplasm","Recurrent Malignant Thyroid Gland Neoplasm","Recurrent Malignant Urinary System Neoplasm","Refractory Cutaneous Melanoma","Refractory Malignant Bone Neoplasm","Refractory Malignant Endocrine Neoplasm","Refractory Malignant Female Reproductive System Neoplasm","Refractory Malignant Male Reproductive System Neoplasm","Refractory Malignant Mesothelioma","Refractory Malignant Neoplasm of Multiple Primary Sites","Refractory Malignant Oral Neoplasm","Refractory Malignant Pharyngeal Neoplasm","Refractory Malignant Skin Neoplasm","Refractory Malignant Soft Tissue Neoplasm","Refractory Malignant Solid Neoplasm","Refractory Malignant Thyroid Gland Neoplasm","Refractory Malignant Urinary System Neoplasm"],"enrollment":12,"completionDate":"2026-02-26"},{"nctId":"NCT06563245","phase":"PHASE2,PHASE3","title":"Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment","status":"RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2024-09-25","conditions":["Classical Hodgkin Lymphoma","Child","Adolescent","Young Adult","Metabolic Response","Survival","Treatment","Brentuximab Vedotin","PET Scan"],"enrollment":96,"completionDate":"2039-11-15"},{"nctId":"NCT02405676","phase":"PHASE2,PHASE3","title":"BNHL-2015 for Children or Adolescents in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2015-01-01","conditions":["Mature B-cell Non-Hodgkin Lymphoma"],"enrollment":200,"completionDate":"2029-12"},{"nctId":"NCT04881838","phase":"PHASE3","title":"CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2021-03-01","conditions":["Pediatric Anaplastic Large Cell Lymphoma"],"enrollment":172,"completionDate":"2029-03-01"},{"nctId":"NCT07481669","phase":"PHASE2","title":"ASCT With TEAM Conditioning for Lymphoma With High Risk of CNS Relapse","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2026-03-01","conditions":["Lymphoma Patients With High-risk of Central Nervous System Relapse"],"enrollment":45,"completionDate":"2028-03-31"},{"nctId":"NCT07477756","phase":"","title":"A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2024-09-04","conditions":["Prostate Cancer"],"enrollment":1247,"completionDate":"2025-03-14"},{"nctId":"NCT05681260","phase":"PHASE3","title":"Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","status":"RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2023-02-06","conditions":["T-cell Lymphoblastic Lymphoma"],"enrollment":200,"completionDate":"2029-12-31"},{"nctId":"NCT03418038","phase":"PHASE2","title":"Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2018-03-23","conditions":["Clonal Cytopenia of Undetermined Significance","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Hodgkin Lymphoma","Recurrent Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Lymphoma","Chronic Myelomonocytic Leukemia"],"enrollment":80,"completionDate":"2033-11-02"},{"nctId":"NCT05384821","phase":"PHASE1,PHASE2","title":"Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)","status":"RECRUITING","sponsor":"Centre Oscar Lambret","startDate":"2022-09-14","conditions":["Wilms Tumor"],"enrollment":28,"completionDate":"2028-10"},{"nctId":"NCT02845882","phase":"PHASE3","title":"LBL-2016 for Children or Adolescents in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2016-01","conditions":["Lymphoblastic Lymphoma"],"enrollment":150,"completionDate":"2031-12"},{"nctId":"NCT05142696","phase":"PHASE1,PHASE2","title":"A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2022-07-13","conditions":["Extensive Stage Small Cell Lung Cancer"],"enrollment":24,"completionDate":"2029-03-23"},{"nctId":"NCT00379340","phase":"PHASE3","title":"Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2007-04-30","conditions":["Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor"],"enrollment":395,"completionDate":"2026-11-18"},{"nctId":"NCT02114229","phase":"PHASE2","title":"Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2014-05-14","conditions":["Malignant Rhabdoid Tumor","Atypical Teratoid Rhabdoid Tumor"],"enrollment":125,"completionDate":"2027-09"},{"nctId":"NCT07001995","phase":"PHASE2","title":"Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression","status":"NOT_YET_RECRUITING","sponsor":"Hunan Province Tumor Hospital","startDate":"2026-05-01","conditions":["Small Cell Lung Cancer","Non Small Cell Lung Cancer","Non Small Cell Lung Cancer NSCLC"],"enrollment":30,"completionDate":"2028-12-30"},{"nctId":"NCT07194044","phase":"PHASE1","title":"Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2026-02","conditions":["Metastatic Ewing Sarcoma"],"enrollment":15,"completionDate":"2030-10"},{"nctId":"NCT07472647","phase":"PHASE1,PHASE2","title":"SYS6090 Combination Therapy in Advanced Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Shanghai JMT-Bio Inc.","startDate":"2026-02-28","conditions":["Non-Small Cell Lung Cancer","Small Cell Lung Cancer"],"enrollment":596,"completionDate":"2030-02-28"},{"nctId":"NCT07472517","phase":"PHASE3","title":"DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy","status":"NOT_YET_RECRUITING","sponsor":"Boehringer Ingelheim","startDate":"2026-04-10","conditions":["Small Cell Lung Cancer (SCLC)","Extensive-stage Small Cell Lung Cancer (ES-SCLC)"],"enrollment":670,"completionDate":"2029-04-16"},{"nctId":"NCT06738368","phase":"PHASE2","title":"Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Washington","startDate":"2026-04-01","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia"],"enrollment":30,"completionDate":"2028-07-30"},{"nctId":"NCT03591510","phase":"PHASE2","title":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2019-03-13","conditions":["FLT3-mutated Acute Myeloid Leukemia"],"enrollment":22,"completionDate":"2029-05-18"},{"nctId":"NCT02203526","phase":"PHASE1","title":"Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-08-14","conditions":["Primary Central Nervous System Lymphoma"],"enrollment":93,"completionDate":"2027-06-15"},{"nctId":"NCT05453500","phase":"PHASE2","title":"Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Washington","startDate":"2023-03-27","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative"],"enrollment":30,"completionDate":"2031-05-01"},{"nctId":"NCT06449209","phase":"PHASE2","title":"Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioNTech SE","startDate":"2024-08-05","conditions":["Extensive-stage Small-cell Lung Cancer","Small-cell Lung Cancer"],"enrollment":110,"completionDate":"2028-05"},{"nctId":"NCT06157827","phase":"PHASE1,PHASE2","title":"A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma","status":"RECRUITING","sponsor":"Nanjing Leads Biolabs Co.,Ltd","startDate":"2023-12-08","conditions":["Advanced Neuroendocrine Carcinoma"],"enrollment":178,"completionDate":"2027-03-28"},{"nctId":"NCT02213913","phase":"PHASE1,PHASE2","title":"Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2014-07-29","conditions":["Adult Grade III Lymphomatoid Granulomatosis","B-cell Chronic Lymphocytic Leukemia","Contiguous Stage II Adult Diffuse Large Cell Lymphoma","Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma","Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma","Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma","Contiguous Stage II Grade 1 Follicular Lymphoma","Contiguous Stage II Grade 2 Follicular Lymphoma","Contiguous Stage II Grade 3 Follicular Lymphoma","Contiguous Stage II Mantle Cell Lymphoma","Contiguous Stage II Marginal Zone Lymphoma","Contiguous Stage II Small Lymphocytic Lymphoma","Cutaneous B-cell Non-Hodgkin Lymphoma","Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue","Intraocular Lymphoma","Nodal Marginal Zone B-cell Lymphoma","Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma","Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma","Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma","Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma","Noncontiguous Stage II Grade 1 Follicular Lymphoma","Noncontiguous Stage II Grade 2 Follicular Lymphoma","Noncontiguous Stage II Grade 3 Follicular Lymphoma","Noncontiguous Stage II Mantle Cell Lymphoma","Noncontiguous Stage II Marginal Zone Lymphoma","Noncontiguous Stage II Small Lymphocytic Lymphoma","Progressive Hairy Cell Leukemia, Initial Treatment","Small Intestine Lymphoma","Splenic Marginal Zone Lymphoma","Stage 0 Chronic Lymphocytic Leukemia","Stage I Adult Diffuse Large Cell Lymphoma","Stage I Adult Diffuse Mixed Cell Lymphoma","Stage I Adult Diffuse Small Cleaved Cell Lymphoma","Stage I Adult Hodgkin Lymphoma","Stage I Adult Immunoblastic Large Cell Lymphoma","Stage I Chronic Lymphocytic Leukemia","Stage I Grade 1 Follicular Lymphoma","Stage I Grade 2 Follicular Lymphoma","Stage I Grade 3 Follicular Lymphoma","Stage I Mantle Cell Lymphoma","Stage I Marginal Zone Lymphoma","Stage I Small Lymphocytic Lymphoma","Stage II Adult Hodgkin Lymphoma","Stage II Chronic Lymphocytic Leukemia","Stage II Small Lymphocytic Lymphoma","Stage III Adult Diffuse Large Cell Lymphoma","Stage III Adult Diffuse Mixed Cell Lymphoma","Stage III Adult Diffuse Small Cleaved Cell Lymphoma","Stage III Adult Hodgkin Lymphoma","Stage III Adult Immunoblastic Large Cell Lymphoma","Stage III Chronic Lymphocytic Leukemia","Stage III Grade 1 Follicular Lymphoma","Stage III Grade 2 Follicular Lymphoma","Stage III Grade 3 Follicular Lymphoma","Stage III Mantle Cell Lymphoma","Stage III Marginal Zone Lymphoma","Stage III Small Lymphocytic Lymphoma","Stage IV Adult Diffuse Large Cell Lymphoma","Stage IV Adult Diffuse Mixed Cell Lymphoma","Stage IV Adult Diffuse Small Cleaved Cell Lymphoma","Stage IV Adult Hodgkin Lymphoma","Stage IV Adult Immunoblastic Large Cell Lymphoma","Stage IV Chronic Lymphocytic Leukemia","Stage IV Grade 1 Follicular Lymphoma","Stage IV Grade 2 Follicular Lymphoma","Stage IV Grade 3 Follicular Lymphoma","Stage IV Mantle Cell Lymphoma","Stage IV Marginal Zone Lymphoma","Stage IV Small Lymphocytic Lymphoma","Testicular Lymphoma","Untreated Hairy Cell Leukemia","Waldenström Macroglobulinemia"],"enrollment":55,"completionDate":"2024-10-29"},{"nctId":"NCT06713837","phase":"PHASE3","title":"IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2025-02-27","conditions":["Acute Myeloid Leukemia","Relapse/Recurrence"],"enrollment":339,"completionDate":"2028-01"},{"nctId":"NCT06193759","phase":"PHASE1","title":"Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)","status":"RECRUITING","sponsor":"Children's National Research Institute","startDate":"2024-09-20","conditions":["Medulloblastoma, Childhood","Atypical Teratoid/Rhabdoid Tumor of CNS","Embryonal Tumor With Multilayered Rosettes","Pineoblastoma","Embryonal Brain Tumor Not Otherwise Specified","Ependymoma"],"enrollment":12,"completionDate":"2032-12-29"},{"nctId":"NCT02402920","phase":"PHASE1","title":"Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2015-07-22","conditions":["Extensive Stage Small Cell Lung Carcinoma","Limited Stage Small Cell Lung Carcinoma","Neuroendocrine Neoplasm"],"enrollment":83,"completionDate":"2026-02-09"},{"nctId":"NCT02867956","phase":"PHASE2","title":"Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2016-08-10","conditions":["Ovarian Cancer"],"enrollment":35,"completionDate":"2019-09-10"},{"nctId":"NCT05091567","phase":"PHASE3","title":"A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2021-11-18","conditions":["Small-Cell Lung Cancer"],"enrollment":660,"completionDate":"2026-08-13"},{"nctId":"NCT03458260","phase":"PHASE2","title":"Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma","status":"COMPLETED","sponsor":"The Lymphoma Academic Research Organisation","startDate":"2018-12-26","conditions":["Aggressive Non-Hodgkin Lymphoma"],"enrollment":74,"completionDate":"2024-12-24"},{"nctId":"NCT07459634","phase":"PHASE2","title":"A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC","status":"NOT_YET_RECRUITING","sponsor":"Jazz Pharmaceuticals","startDate":"2026-04-25","conditions":["Extensive-stage Small-cell Lung Cancer"],"enrollment":50,"completionDate":"2028-04-30"},{"nctId":"NCT05533775","phase":"PHASE1,PHASE2","title":"A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2022-11-16","conditions":["Mature B-Cell Non-Hodgkin Lymphoma"],"enrollment":65,"completionDate":"2032-11-30"},{"nctId":"NCT05540340","phase":"PHASE1","title":"A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2022-09-09","conditions":["Lymphoma","Lymphoma, B-Cell","Lymphoma, T-Cell","Lymphoma, Hodgkin","Lymphoma, Non-Hodgkin"],"enrollment":39,"completionDate":"2027-09"},{"nctId":"NCT06401330","phase":"PHASE3","title":"A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2025-04-15","conditions":["Stage I Mixed Cell Type Kidney Wilms Tumor","Stage II Mixed Cell Type Kidney Wilms Tumor","Stage III Mixed Cell Type Kidney Wilms Tumor","Stage IV Mixed Cell Type Kidney Wilms Tumor"],"enrollment":1656,"completionDate":"2031-02-13"},{"nctId":"NCT07449481","phase":"PHASE2","title":"A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2026-02-01","conditions":["Malignant Solid Tumor","Brain Metastasis","Microtubule Inhibitors","Anti-angiogenic Targeted Drugs"],"enrollment":56,"completionDate":"2030-02-01"},{"nctId":"NCT05068232","phase":"PHASE2","title":"Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2022-08-19","conditions":["Small-cell Lung Cancer","Extensive-stage Small-cell Lung Cancer","Lung Cancer"],"enrollment":49,"completionDate":"2027-10-01"},{"nctId":"NCT06646276","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-02-25","conditions":["Extensive-Stage Small Cell Lung Cancer"],"enrollment":530,"completionDate":"2031-09-05"},{"nctId":"NCT04231877","phase":"PHASE1","title":"Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma","status":"RECRUITING","sponsor":"University of Washington","startDate":"2020-10-27","conditions":["Aggressive Non-Hodgkin Lymphoma","ALK-Positive Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-Cell Lymphoma","T-Cell/Histiocyte-Rich Large B-Cell Lymphoma","Gray-Zone Lymphoma"],"enrollment":56,"completionDate":"2031-12-01"},{"nctId":"NCT04663347","phase":"PHASE1,PHASE2","title":"Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genmab","startDate":"2020-11-03","conditions":["Diffuse Large B-Cell Lymphoma","Follicular Lymphoma"],"enrollment":543,"completionDate":"2027-09-30"},{"nctId":"NCT06719700","phase":"PHASE2","title":"Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-11-30","conditions":["Toripalimab","Surufatinib","Chemoradiotherapy","Limited-stage Small Cell Lung Cancer (LS-SCLC)"],"enrollment":47,"completionDate":"2028-11-29"},{"nctId":"NCT05361395","phase":"PHASE1","title":"First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2022-08-24","conditions":["Extensive Stage Small Cell Lung Cancer"],"enrollment":184,"completionDate":"2028-08-28"},{"nctId":"NCT05605899","phase":"PHASE3","title":"Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma","status":"RECRUITING","sponsor":"Kite, A Gilead Company","startDate":"2023-02-10","conditions":["High-risk Large B-cell Lymphoma (LBCL)"],"enrollment":300,"completionDate":"2031-03"},{"nctId":"NCT02574728","phase":"PHASE2","title":"Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Emory University","startDate":"2015-06","conditions":["Cancer"],"enrollment":46,"completionDate":"2026-06"},{"nctId":"NCT04486391","phase":"PHASE3","title":"Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma","status":"TERMINATED","sponsor":"BeiGene","startDate":"2020-12-14","conditions":["Classical Hodgkin Lymphoma"],"enrollment":3,"completionDate":"2025-10-13"},{"nctId":"NCT00716066","phase":"PHASE2","title":"Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fred Hutchinson Cancer Center","startDate":"2008-06","conditions":["Autoimmune Disease","Neurologic Autoimmune Disease","Autologous Transplant Autoimmune","Multiple Sclerosis Transplant","MS Stem Cell Transplant","Multiple Sclerosis Stem Cell Transplant","Stiff Person Syndrome","HCT for Neurologic Autoimmune Disorders","CIDP Transplant","Myasthenia Gravis Transplant","Autoimmune Nervous System Disorder","Central Nervous System Vasculitis","Cerebellar Degeneration","Chronic Inflammatory Demyelinating Polyneuropathy","Lambert Eaton Myasthenic Syndrome","Myasthenia Gravis","Neuromyelitis Optica","Opsoclonus Myoclonus Syndrome","Rasmussen Subacute Encephalitis"],"enrollment":53,"completionDate":"2030-01-31"},{"nctId":"NCT03067181","phase":"PHASE3","title":"Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2017-05-25","conditions":["Childhood Extracranial Germ Cell Tumor","Extragonadal Embryonal Carcinoma","Germ Cell Tumor","Malignant Germ Cell Tumor","Malignant Ovarian Teratoma","Stage I Ovarian Choriocarcinoma","Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage I Testicular Choriocarcinoma AJCC v6 and v7","Stage I Testicular Embryonal Carcinoma AJCC v6 and v7","Stage I Testicular Seminoma AJCC v6 and v7","Stage I Testicular Yolk Sac Tumor AJCC v6 and v7","Stage II Ovarian Choriocarcinoma","Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage II Testicular Choriocarcinoma AJCC v6 and v7","Stage II Testicular Embryonal Carcinoma AJCC v6 and v7","Stage II Testicular Yolk Sac Tumor AJCC v6 and v7","Stage III Ovarian Choriocarcinoma","Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage III Testicular Choriocarcinoma AJCC v6 and v7","Stage III Testicular Embryonal Carcinoma AJCC v6 and v7","Stage III Testicular Yolk Sac Tumor AJCC v6 and v7","Stage IV Ovarian Choriocarcinoma","Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7","Testicular Mixed Choriocarcinoma and Embryonal Carcinoma","Testicular Mixed Choriocarcinoma and Teratoma","Testicular Mixed Choriocarcinoma and Yolk Sac Tumor"],"enrollment":1780,"completionDate":"2027-06-30"},{"nctId":"NCT04602533","phase":"PHASE2","title":"Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Michael Hopp","startDate":"2020-12-21","conditions":["Small Cell Lung Cancer Limited Stage"],"enrollment":105,"completionDate":"2026-12-31"},{"nctId":"NCT03126916","phase":"PHASE3","title":"Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2018-05-14","conditions":["Ganglioneuroblastoma","Ganglioneuroblastoma, Nodular","Neuroblastoma"],"enrollment":750,"completionDate":"2030-09-30"},{"nctId":"NCT06942039","phase":"EARLY_PHASE1","title":"Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation","status":"RECRUITING","sponsor":"C17 Council","startDate":"2025-09-23","conditions":["CNS Embryonal Tumor","CNS, Medulloblastoma","Atypical Teratoid Rhabdoid Tumor","Medulloblastoma, Childhood","Medulloblastoma, Group 3","Medulloblastoma, Group 4","Pineoblastoma","Neuroblastoma","Embryonal Tumor With Multilayered Rosettes","Embryonal Tumor With Abundant Neuropil and True Rosettes","Ependymoblastoma","Medulloepithelioma","CNS Embryonal Tumor With Rhabdoid Features","CNS Embryonal Tumor, Nos"],"enrollment":15,"completionDate":"2032-12-31"},{"nctId":"NCT07005128","phase":"PHASE3","title":"A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)","status":"RECRUITING","sponsor":"Amgen","startDate":"2025-08-18","conditions":["Small-cell Lung Cancer","Extensive Stage Small-cell Lung Cancer"],"enrollment":330,"completionDate":"2029-07-15"},{"nctId":"NCT04469530","phase":"PHASE2","title":"Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors","status":"RECRUITING","sponsor":"Emory University","startDate":"2020-09-16","conditions":["Solid Tumor"],"enrollment":55,"completionDate":"2029-02"},{"nctId":"NCT05815160","phase":"PHASE1","title":"Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Debiopharm International SA","startDate":"2023-05-02","conditions":["Small Cell Lung Cancer Recurrent"],"enrollment":34,"completionDate":"2026-03"},{"nctId":"NCT04293562","phase":"PHASE3","title":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2020-07-21","conditions":["Acute Myeloid Leukemia"],"enrollment":1186,"completionDate":"2029-06-30"},{"nctId":"NCT04684368","phase":"PHASE2","title":"A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2021-07-13","conditions":["Central Nervous System Nongerminomatous Germ Cell Tumor","Choriocarcinoma","Embryonal Carcinoma","Immature Teratoma","Malignant Teratoma","Mixed Germ Cell Tumor","Pineal Region Germ Cell Tumor","Pineal Region Immature Teratoma","Pineal Region Yolk Sac Tumor","Suprasellar Germ Cell Tumor"],"enrollment":160,"completionDate":"2029-12-21"},{"nctId":"NCT05683977","phase":"","title":"A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2022-11-14","conditions":["Small Cell Lung Carcinoma"],"enrollment":254,"completionDate":"2027-03-01"},{"nctId":"NCT06368817","phase":"PHASE2","title":"A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2024-10-22","conditions":["Basal Ganglia Germinoma","Central Nervous System Germinoma","Diabetes Insipidus","Pineal Region Germinoma","Suprasellar Germinoma","Thalamic Germinoma"],"enrollment":240,"completionDate":"2033-11-04"},{"nctId":"NCT04322318","phase":"PHASE2","title":"A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2020-10-19","conditions":["Anaplastic Kidney Wilms Tumor","Recurrent Kidney Wilms Tumor","Stage II Kidney Wilms Tumor","Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor"],"enrollment":256,"completionDate":"2027-07-01"},{"nctId":"NCT05432635","phase":"PHASE1","title":"Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2023-08-01","conditions":["B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Mantle Cell Lymphoma","Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Mantle Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Transformed Non-Hodgkin Lymphoma"],"enrollment":15,"completionDate":"2028-12-30"},{"nctId":"NCT01356290","phase":"PHASE2","title":"Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors","status":"RECRUITING","sponsor":"Medical University of Vienna","startDate":"2014-04","conditions":["Medulloblastoma Recurrent","Ependymoma Recurrent","ATRT Recurrent","Rare CNS Tumor Recurrent"],"enrollment":232,"completionDate":"2030-04"},{"nctId":"NCT01946529","phase":"PHASE2","title":"Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2013-12-27","conditions":["Desmoplastic Small Round Cell Tumor","Ewing Sarcoma of Bone or Soft Tissue","Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor","Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor"],"enrollment":24,"completionDate":"2026-07"},{"nctId":"NCT03007147","phase":"PHASE3","title":"Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2017-08-08","conditions":["Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia","T Acute Lymphoblastic Leukemia"],"enrollment":475,"completionDate":"2027-09-30"},{"nctId":"NCT03755804","phase":"PHASE2","title":"Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2018-12-12","conditions":["Hodgkin Lymphoma"],"enrollment":232,"completionDate":"2028-07-01"},{"nctId":"NCT06830694","phase":"PHASE2","title":"Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment","status":"RECRUITING","sponsor":"Se-Hoon Lee","startDate":"2025-05-13","conditions":["Small Cell Carcinoma of Lung"],"enrollment":50,"completionDate":"2027-06-30"},{"nctId":"NCT05991388","phase":"PHASE2,PHASE3","title":"A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma","status":"RECRUITING","sponsor":"University of Birmingham","startDate":"2024-05-02","conditions":["B-cell Non Hodgkin Lymphoma"],"enrollment":210,"completionDate":"2033-05-01"},{"nctId":"NCT04002947","phase":"PHASE2","title":"Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-08-05","conditions":["Non-Hodgkin's Lymphoma","Diffuse Large B-Cell Lymphoma","DLBCL","NHL"],"enrollment":132,"completionDate":"2030-03-31"},{"nctId":"NCT05389423","phase":"PHASE1","title":"Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-06-27","conditions":["Diffuse Large Cell Lymphoma","Non-Hodgkin Lymphoma","Burkitt Lymphoma","Plasmablastic Lymphoma","B-Cell Neoplasm"],"enrollment":25,"completionDate":"2032-06-01"},{"nctId":"NCT03407144","phase":"PHASE2","title":"Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-04-09","conditions":["Hodgkin Lymphoma"],"enrollment":340,"completionDate":"2026-11-06"},{"nctId":"NCT05403723","phase":"PHASE1","title":"Adaptive SBRT Plus Chemoimmunotherapy for ES-SCLC","status":"SUSPENDED","sponsor":"University of Maryland, Baltimore","startDate":"2026-06-30","conditions":["Extensive-stage Small-cell Lung Cancer"],"enrollment":50,"completionDate":"2027-08"},{"nctId":"NCT04570423","phase":"PHASE2","title":"A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","status":"RECRUITING","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2021-05-20","conditions":["Solid Tumors","Lymphoma"],"enrollment":40,"completionDate":"2027-10"},{"nctId":"NCT05504291","phase":"PHASE2","title":"A Study to Give Treatment Inside the Eye to Treat Retinoblastoma","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2022-11-04","conditions":["Bilateral Retinoblastoma","Childhood Intraocular Retinoblastoma","Group D Retinoblastoma","Stage I Retinoblastoma","Unilateral Retinoblastoma"],"enrollment":26,"completionDate":"2028-03-31"},{"nctId":"NCT07149363","phase":"PHASE2","title":"Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Alliance Foundation Trials, LLC.","startDate":"2026-02","conditions":["Small Cell Lung Cancer (SCLC)"],"enrollment":65,"completionDate":"2031-02"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Capsule, Injection","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"Etoposide"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"Etoposide"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Etoposide"},{"form":"INJECTION, SOLUTION, CONCENTRATE","route":"INTRAVENOUS","productName":"Toposar"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146478","MMSL":"4209","NDDF":"002674","UNII":"6PLQ3CP4P3","VUID":"4018141","CHEBI":"CHEBI:4911","VANDF":"4018141","INN_ID":"3835","RXNORM":"220347","UMLSCUI":"C0015133","chemblId":"CHEMBL1200645","ChEMBL_ID":"CHEMBL44657","KEGG_DRUG":"D00125","DRUGBANK_ID":"DB00773","PDB_CHEM_ID":" EVP","PUBCHEM_CID":"36462","SNOMEDCT_US":"387316009","IUPHAR_LIGAND_ID":"6815","MESH_DESCRIPTOR_UI":"D005047"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Onesource Specialty","relationship":"Current Owner"},{"period":"2019","companyName":"Bristol-Myers Squibb K.K.","relationship":"PMDA Licensee"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"5.7 hours","clearance":"0.5 mL/min/kg","bioavailability":"52%","fractionUnbound":"0.12%","volumeOfDistribution":"0.18 L/kg"},"publicationCount":24207,"therapeuticAreas":["Oncology"],"atcClassification":{"source":"DrugCentral","atcCode":"L01CB01","allCodes":["L01CB01"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 26","pmid":"41903672","title":"Oral solid lipid nanoparticles of etoposide enable metronomic-like therapy with reduced toxicity in MYCN-amplified neuroblastoma.","journal":"Cancer letters"},{"date":"2026 Feb 25","pmid":"41898155","title":"Synergistic Antitumor Effects of Etoposide and Curcumin in Ovarian Cancer Cells.","journal":"Biomedicines"},{"date":"2026 Mar 1","pmid":"41897459","title":"3,6'-Disinapoyl Sucrose from Polygalae Radix Exerts Anti-Aging Effects via Modification of Telomeres, SIRT1/p53/p21 Pathway, Oxidative Stress and Autophagy.","journal":"Antioxidants (Basel, Switzerland)"},{"date":"2026 Mar 27","pmid":"41896432","title":"Potential of SERS and proteomics for biomarker detection in cancer cells.","journal":"Analytical and bioanalytical chemistry"},{"date":"2026 Mar 27","pmid":"41888388","title":"Topoisomerase I/II inhibitors: from established drugs to next-generation therapeutics.","journal":"Inflammopharmacology"}],"companionDiagnostics":[],"genericManufacturers":14,"_genericFilersChecked":true,"genericManufacturerList":["Accord Hlthcare","Dash Pharms","Dash Pharms Natco","Fresenius Kabi Usa","Hikma","Hospira","Meitheal","Mylan","Pharmachemie Bv","Pierre Fabre","Teva Parenteral","Teva Pharms Usa","Watson Labs","Watson Labs Inc"],"status":"active","companyName":"Onesource Specialty","companyId":"bristol-myers-squibb","modality":"Small Molecule","firstApprovalDate":"1983","enrichmentLevel":3,"visitCount":4,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-03-14T00:00:00.000Z","mah":"ACCORD HLTHCARE","brand_name_local":null,"application_number":"ANDA074513"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-11-20T00:00:00.000Z","mah":"HIKMA","brand_name_local":null,"application_number":"ANDA074290"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1999-11-19T00:00:00.000Z","mah":"MEITHEAL","brand_name_local":null,"application_number":"ANDA074529"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-11-09T00:00:00.000Z","mah":"CHEPLAPHARM","brand_name_local":null,"application_number":"NDA020457"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2026-02-13T00:00:00.000Z","mah":"AVYXA HOLDINGS","brand_name_local":null,"application_number":"NDA220200"},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":51,"withResults":28},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:52:54.658317+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}