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A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
Phase 1, PHASE2 trial testing Nab-paclitaxel in Adenocarcinoma in 48 participants. Completed in 3 October 2022.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 21 June 2018 |
| Primary completion | 3 October 2022 |
| Estimated completion | 3 October 2022 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Adults 18 to 76, any sex, with Adenocarcinoma or Pancreatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
| Group | Value | 95% CI |
|---|---|---|
| Phase I | 500 |
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 | 125 |
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
| Group | Value | 95% CI |
|---|---|---|
| Phase I | 500 |
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 | 20 |
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 | 20 |
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 MTD/ Phase 2 | 5.92 | 5.52 – NA |
Number of patients who received the MTD (Cohort 1, Dose Level 5) that experienced a limiting toxicity. Limiting toxicity was defined as a grade 3 or above treatment-related toxicity, with the following exceptions: 1. Grade 3 anemia that resolves to \< grade 2 within 7 days; 2. Grade 3 thrombocytopenia without clinically significant bleeding that resolves to \< grade 2 within 7 days; 3. Grade 3 or 4 neutropenia that resolves to \<grade 2 within 7 days; 4. Grade 3 or 4 leucopenia/lymphopenia; 5. Grade 3 nausea, vomiting, or diarrhea that resolves to \<grade 2 within 72 hours; 6. Grade 3 or 4 asy
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 MTD/ Phase 2 | 3 |
Time frame: All-Cause Mortality was assessed for up to 51 months for patients in both Phase 1 and Phase 2 portions of the trial. Serious and Other (Not Including Serious) Adverse Events were assessed up to 45 months for patients in both Phase 1 and 2 portions of the trial.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 2, Dose Le… | Phase 1, Cohort 2, Dose Le… | Phase 1, Cohort 2, Dose Le… | Phase 2 MTD Dose Expansion |
|---|---|---|---|---|---|---|---|---|---|---|
| Disease progression-Death | General disorders | — | — | — | — | — | — | — | — | — |
| Thromboembolic event | Vascular disorders | — | — | — | — | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Colonic obstruction | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Duodenal ulcer | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Esophageal varices hemorrhage | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Hematemesis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Obstruction gastric | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — |
| Bile duct stenosis | Hepatobiliary disorders | — | — | — | — | — | — | — | — | — |
| Biliary tract infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Enterocolitis infectious | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Pseudocyst infection | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Liver abscess | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — | — | — | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Reaction | System | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 1, Dose Le… | Phase 1, Cohort 2, Dose Le… | Phase 1, Cohort 2, Dose Le… | Phase 1, Cohort 2, Dose Le… | Phase 2 MTD Dose Expansion |
|---|---|---|---|---|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — | — | — |
| Weight loss | Investigations | — | — | — | — | — | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — | — | — | — |
| Blurred vision | Eye disorders | — | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Bloating | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — | — | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — | — | — | — | — |
| Weight gain | Investigations | — | — | — | — | — | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — | — | — | — | — | — |
| Pain in extremities | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — | — |
| Lipoma and other skin nodules | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — | — | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — | — | — | — | — | — | — |
| Hearing impaired | Ear and labyrinth disorders | — | — | — | — | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
| Cheilitis | Gastrointestinal disorders | — | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Disease progression-Death, Thromboembolic event, Anemia, Atrial fibrillation, Myocardial infarction, Supraventricular tachycardia, Abdominal pain, Colonic obstruction.
Data from ClinicalTrials.gov NCT03535727 adverse events section.
The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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