{"id":"copanlisib","rwe":[],"tags":[{"label":"Kinase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform","category":"target"},{"label":"PIK3CA","category":"gene"},{"label":"PIK3CD","category":"gene"},{"label":"PIK3CB","category":"gene"},{"label":"L01EM02","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Follicular lymphoma","category":"indication"},{"label":"Bayer Healthcare","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":62.284,"date":"","count":23,"signal":"Rash maculo-papular","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=62)"},{"llr":60.499,"date":"","count":9,"signal":"Metastases to retroperitoneum","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=60)"},{"llr":60.185,"date":"","count":9,"signal":"Metastases to muscle","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=60)"},{"llr":59.47,"date":"","count":19,"signal":"Neutropenic sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=59)"},{"llr":57.955,"date":"","count":18,"signal":"Cytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=58)"},{"llr":57.019,"date":"","count":53,"signal":"Pyrexia","source":"DrugCentral FAERS","actionTaken":"Reported 53 times (LLR=57)"},{"llr":55.691,"date":"","count":9,"signal":"Metastases to spleen","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=56)"},{"llr":55.205,"date":"","count":23,"signal":"Hyperglycaemia","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=55)"},{"llr":51.412,"date":"","count":9,"signal":"Metastases to bone marrow","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=51)"},{"llr":50.733,"date":"","count":13,"signal":"Cytomegalovirus infection reactivation","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=51)"},{"llr":48.616,"date":"","count":15,"signal":"End stage renal disease","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=49)"}],"commonSideEffects":[],"specialPopulations":{"Lactation":"There are no data on the presence of copanlisib and/or metabolites in human milk, the effects on the breastfed child, or on milk production. Following administration of radiolabeled copanlisib to lactating rats, approximately 2% of the radioactivity was secreted into milk; the milk to plasma ratio of radioactivity was 25-fold. Because of the potential for serious adverse reactions in breastfed child from copanlisib, advise lactating woman not to breastfeed during treatment.","Pregnancy":"Based on findings from animal studies and the mechanism of action, ALIQOPA can cause fetal harm when administered to pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis resulted in embryo-fetal death and fetal abnormalities at maternal doses approximately 12% of the recommended dose for patients. Advise pregnant women of the potential risk to fetus.","Geriatric use":"No dose adjustment is necessary in patients >=65 years of age. Of 168 patients with follicular lymphoma and other hematologic malignancies treated with ALIQOPA, 48% were age 65 or older while 16% were age 75 or older. No clinically relevant differences in efficacy were observed between elderly and younger patients. In patients >=65 years of age, 30% experienced serious adverse reactions and 21% experienced adverse reactions leading to discontinuation.","Paediatric use":"Safety and effectiveness have not been established in pediatric patients."}},"trials":[],"aliases":[],"company":"Bayer","patents":[{"applNo":"N209936","source":"FDA Orange Book","status":"Active","expires":"Mar 29, 2032","useCode":"U-2124","territory":"US","drugProduct":false,"patentNumber":"9636344","drugSubstance":false},{"applNo":"N209936","source":"FDA Orange Book","status":"Active","expires":"Oct 22, 2029","useCode":"U-2124","territory":"US","drugProduct":true,"patentNumber":"RE46856","drugSubstance":true},{"applNo":"N209936","source":"FDA Orange Book","status":"Active","expires":"Mar 29, 2032","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10383876","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=COPANLISIB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T06:02:41.479920+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T06:02:41.479414+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Copanlisib","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T06:02:58.275029+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=COPANLISIB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T06:02:57.703814+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: PI3-kinase p110-delta subunit inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:02:58.274701+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3218576/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:02:58.176643+00:00"}},"allNames":"aliqopa","offLabel":[],"synonyms":["copanlisib","BAY 80-6946","BAY 84-1236","copanlisib hydrochloride","copanlisib HCl","copanlisib hydrochloride hydrate"],"timeline":[{"date":"2017-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BAYER HEALTHCARE PHARMS to Bayer Healthcare"},{"date":"2017-09-14","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bayer Healthcare Pharms)"},{"date":"2029-10-22","type":"negative","source":"FDA Orange Book","milestone":"Substance patent RE46856 expires"},{"date":"2032-03-29","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 10383876 expires"}],"aiSummary":"Aliqopa (COPANLISIB) is a small molecule kinase inhibitor developed by Bayer Healthcare, targeting the phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform. It was FDA-approved in 2017 for the treatment of follicular lymphoma. Aliqopa is a patented medication with no generic manufacturers available. Key safety considerations include its potential for severe side effects such as neutropenia and thrombocytopenia. It has a half-life of approximately 25.2 hours.","approvals":[{"date":"2017-09-14","orphan":true,"company":"BAYER HEALTHCARE PHARMS","regulator":"FDA"}],"brandName":"Aliqopa","ecosystem":[{"indication":"Follicular lymphoma","otherDrugs":[{"name":"interferon alfa-2b","slug":"interferon-alfa-2b","company":"Schering"},{"name":"lenalidomide","slug":"lenalidomide","company":"Celgene"},{"name":"rituximab","slug":"rituximab","company":"Genentech"},{"name":"tazemetostat","slug":"tazemetostat","company":"Epizyme Inc"}],"globalPrevalence":120000}],"mechanism":{"target":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform","novelty":"Follow-on","targets":[{"gene":"PIK3CA","source":"DrugCentral","target":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform","protein":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform"},{"gene":"PIK3CD","source":"DrugCentral","target":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform","protein":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform"},{"gene":"PIK3CB","source":"DrugCentral","target":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform","protein":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform"},{"gene":"PIK3CG","source":"DrugCentral","target":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform","protein":"Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform"},{"gene":"MTOR","source":"DrugCentral","target":"Serine/threonine-protein kinase mTOR","protein":"Serine/threonine-protein kinase mTOR"},{"gene":"RAB27A","source":"DrugCentral","target":"Ras-related protein Rab-27A","protein":"Ras-related protein Rab-27A"}],"moaClass":"Kinase Inhibitors","modality":"Small Molecule","drugClass":"Kinase Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Aliqopa specifically inhibits the PI3Kα isoform, a key enzyme in the PI3K/AKT signaling pathway, which is often dysregulated in follicular lymphoma, leading to uncontrolled cell growth and proliferation."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Copanlisib","title":"Copanlisib","extract":"Copanlisib, sold under the brand name Aliqopa, is a medication used for the treatment of adults experiencing relapsed follicular lymphoma who have received at least two prior systemic therapies.","wiki_history":"== History ==\nEfficacy resulting in the approval of copanlisib was based on the subgroup of 104 patients with follicular lymphoma from a phase II clinical trial.\n\n=== Clinical trials ===\nPhase II clinical trials are in progress for treatment of endometrial cancer, diffuse large B-cell lymphoma, cholangiocarcinoma, and non-Hodgkin lymphoma. Copanlisib in combination with R-CHOP or R-B (rituximab and bendamustine) is in a phase III trial for relapsed indolent non-Hodgkin lymphoma (NHL). Two separate phase III trials are investigating the use of copanlisib in combination with rituximab for indolent NHL and the other using copanlisib alone in cases of rituximab-refractory indolent NHL.\n\nIn a preclinical study, copanlisib was effective in inhibiting HER2+ breast cancer cells with acquired resistance to the HER2-inhibitors trastuzumab and/or lapatinib. This effect was increased when copanlisib was administered along with the aforementioned HER2-inhibitors. Consequently, treatments of copanlisib with trastuzumab are being clinically trialled in HER2-positive breast cancer patients.","wiki_society_and_culture":"== Society and culture ==\n\n=== Legal status ===\nFor follicular lymphoma, the U.S. Food and Drug Administration (FDA) awarded copanlisib orphan drug designation in February 2015, and fast track designation in February 2016. The New drug application for follicular lymphoma was granted priority review in May 2017.\n\nCopanlisib was granted orphan drug status for the treatment of splenic, nodal and extranodal subtypes of marginal zone lymphoma."},"commercial":{"launchDate":"2017","_launchSource":"DrugCentral (FDA 2017-09-14, BAYER HEALTHCARE PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5256","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=COPANLISIB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=COPANLISIB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Copanlisib","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":"2026-03-30T10:17:50.045904","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T06:02:59.991541+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"idelalisib","drugSlug":"idelalisib","fdaApproval":"2014-07-23","patentExpiry":"Sep 2, 2033","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"alpelisib","drugSlug":"alpelisib","fdaApproval":"2019-04-24","patentExpiry":"Sep 10, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"duvelisib","drugSlug":"duvelisib","fdaApproval":"2018-09-24","patentExpiry":"May 17, 2032","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"copanlisib","indications":{"approved":[{"name":"Follicular lymphoma","source":"DrugCentral","snomedId":55150002,"regulator":"FDA","eligibility":"adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies","usPrevalence":null,"globalPrevalence":120000,"prevalenceMethod":"curated","prevalenceSource":"IARC GLOBOCAN, 2022"}],"offLabel":[],"pipeline":[]},"currentOwner":"Bayer Healthcare","drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"idelalisib","brandName":"idelalisib","genericName":"idelalisib","approvalYear":"2014","relationship":"same-class"},{"drugId":"alpelisib","brandName":"alpelisib","genericName":"alpelisib","approvalYear":"2019","relationship":"same-class"},{"drugId":"duvelisib","brandName":"duvelisib","genericName":"duvelisib","approvalYear":"2018","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04317105","phase":"PHASE1,PHASE2","title":"Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-07-17","conditions":["Advanced Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm"],"enrollment":54,"completionDate":"2026-12-17"},{"nctId":"NCT06400238","phase":"PHASE2","title":"Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2018-10-15","conditions":["Advanced Lymphoma","Advanced Malignant Solid Neoplasm","Refractory Lymphoma","Refractory Malignant Solid Neoplasm","Refractory Multiple Myeloma"],"enrollment":35,"completionDate":"2026-12-31"},{"nctId":"NCT05490771","phase":"PHASE2","title":"Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2018-06-20","conditions":["Advanced Lymphoma","Advanced Malignant Solid Neoplasm","Hematopoietic and Lymphatic System Neoplasm","Refractory Lymphoma","Refractory Malignant Solid Neoplasm","Refractory Multiple Myeloma"],"enrollment":35,"completionDate":"2027-01-15"},{"nctId":"NCT03502733","phase":"PHASE1","title":"Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2018-08-14","conditions":["Lymphoma","Metastatic Malignant Solid Neoplasm","Recurrent Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm"],"enrollment":64,"completionDate":"2026-07-01"},{"nctId":"NCT04345913","phase":"PHASE1,PHASE2","title":"Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-03-01","conditions":["Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Triple-Negative Breast Carcinoma","Unresectable Triple-Negative Breast Carcinoma"],"enrollment":24,"completionDate":"2026-05-07"},{"nctId":"NCT06360588","phase":"PHASE2","title":"Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2018-10-08","conditions":["Malignant Solid Neoplasm"],"enrollment":22,"completionDate":"2027-01-15"},{"nctId":"NCT02465060","phase":"PHASE2","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2015-08-17","conditions":["Advanced Lymphoma","Advanced Malignant Solid Neoplasm","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colon Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Esophageal Carcinoma","Exocrine Pancreas Carcinoma","Gastric Carcinoma","Glioma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Kidney Carcinoma","Liver Carcinoma","Lung Carcinoma","Lymphoma","Malignant Uterine Corpus Neoplasm","Malignant Uterine Neoplasm","Melanoma","Multiple Myeloma","Ovarian Carcinoma","Prostate Carcinoma","Rectal Carcinoma","Recurrent Bladder Carcinoma","Recurrent Breast Carcinoma","Recurrent Cervical Carcinoma","Recurrent Colon Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Gastric Carcinoma","Recurrent Glioma","Recurrent Head and Neck Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Carcinoma","Recurrent Lymphoma","Recurrent Malignant Solid Neoplasm","Recurrent Malignant Uterine Corpus Neoplasm","Recurrent Melanoma","Recurrent Multiple Myeloma","Recurrent Ovarian Carcinoma","Recurrent Pancreatic Carcinoma","Recurrent Prostate Carcinoma","Recurrent Rectal Carcinoma","Recurrent Skin Carcinoma","Recurrent Thyroid Gland Carcinoma","Refractory Lymphoma","Refractory Malignant Solid Neoplasm","Refractory Multiple Myeloma","Skin Carcinoma","Thyroid Gland Carcinoma"],"enrollment":6452,"completionDate":"2026-12-31"},{"nctId":"NCT03586661","phase":"PHASE1","title":"Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-04-29","conditions":["Deleterious BRCA1 Gene Mutation","Deleterious BRCA2 Gene Mutation","Endometrial Adenocarcinoma","High Grade Ovarian Serous Adenocarcinoma","Platinum-Resistant Ovarian Carcinoma","Primary Peritoneal High Grade Serous Adenocarcinoma","Progressive Disease","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma"],"enrollment":31,"completionDate":"2026-12-31"},{"nctId":"NCT03789240","phase":"PHASE2","title":"Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-08-22","conditions":["Follicular Lymphoma","Non-Hodgkin's Lymphoma","NHL"],"enrollment":33,"completionDate":"2027-01-01"},{"nctId":"NCT03581942","phase":"PHASE1,PHASE2","title":"Copanlisib With Ibrutinib for Patients With Recurrent/ Refractory Primary Central Nervous System Lymphoma (PCNSL)","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2018-08-23","conditions":["Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL)"],"enrollment":18,"completionDate":"2026-02-05"},{"nctId":"NCT05082025","phase":"PHASE2","title":"Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-09-27","conditions":["Endometrial Cancer","Ovarian Cancer"],"enrollment":7,"completionDate":"2025-12-12"},{"nctId":"NCT04572763","phase":"PHASE1,PHASE2","title":"Copanlisib Plus Venetoclax in R/R DLBCL","status":"ACTIVE_NOT_RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2021-09-08","conditions":["Diffuse Large B Cell Lymphoma","Relapsed Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma"],"enrollment":48,"completionDate":"2026-07-29"},{"nctId":"NCT03884998","phase":"PHASE1","title":"Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2019-02-26","conditions":["Chronic Lymphocytic Leukemia","Diffuse Large B-Cell Lymphoma","Follicular Lymphoma","Indolent Non-Hodgkin Lymphoma","Lymphoplasmacytic Lymphoma","Marginal Zone Lymphoma","Richter Syndrome"],"enrollment":27,"completionDate":"2026-11-04"},{"nctId":"NCT04895579","phase":"PHASE1","title":"Lung Cancer With Copanlisib and Durvalumab","status":"COMPLETED","sponsor":"Zhonglin Hao","startDate":"2021-05-12","conditions":["Non Small Cell Lung Cancer"],"enrollment":11,"completionDate":"2025-11-12"},{"nctId":"NCT02367040","phase":"PHASE3","title":"Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-08-03","conditions":["Lymphoma,Non-Hodgkin"],"enrollment":458,"completionDate":"2024-11-15"},{"nctId":"NCT03842228","phase":"PHASE1","title":"Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-11-21","conditions":["Advanced Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm"],"enrollment":39,"completionDate":"2026-09-24"},{"nctId":"NCT04108858","phase":"PHASE1,PHASE2","title":"Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2021-05-20","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","HER2-Positive Breast Carcinoma","Metastatic Breast Carcinoma"],"enrollment":2,"completionDate":"2022-04-29"},{"nctId":"NCT03939897","phase":"PHASE1","title":"Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-06-17","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic HER2-Negative Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","Recurrent Breast Carcinoma"],"enrollment":24,"completionDate":"2026-08-14"},{"nctId":"NCT03711058","phase":"PHASE1,PHASE2","title":"Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2019-01-17","conditions":["Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor","Microsatellite Stable (MSS) Colon Cancer"],"enrollment":48,"completionDate":"2025-06-30"},{"nctId":"NCT04462471","phase":"PHASE1","title":"Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2020-06-26","conditions":["Thyroid Carcinoma","Thyroid Cancer","Thyroid Cancer, Follicular","Thyroid Cancer (Follicular Cell)","Thyroid Cancer, Papillary","BRAF V600E Mutation Positive"],"enrollment":8,"completionDate":"2023-09-29"},{"nctId":"NCT04433182","phase":"PHASE2","title":"Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma","status":"TERMINATED","sponsor":"Fondazione Italiana Linfomi - ETS","startDate":"2020-08-18","conditions":["Diffuse Large B-cell Lymphoma"],"enrollment":37,"completionDate":"2024-12-19"},{"nctId":"NCT04042051","phase":"PHASE1","title":"Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer","status":"TERMINATED","sponsor":"Cancer Trials Ireland","startDate":"2019-11-12","conditions":["HER2-positive Breast Cancer","Metastatic Breast Cancer","Locally Advanced Breast Cancer","Unresectable Breast Cancer"],"enrollment":2,"completionDate":"2020-11-02"},{"nctId":"NCT05687721","phase":"PHASE1,PHASE2","title":"Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer","status":"WITHDRAWN","sponsor":"VA Office of Research and Development","startDate":"2025-06-02","conditions":["Advanced Urothelial Carcinoma"],"enrollment":0,"completionDate":"2025-06-02"},{"nctId":"NCT03432741","phase":"PHASE1","title":"Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer","status":"TERMINATED","sponsor":"Mayo Clinic","startDate":"2018-03-27","conditions":["Breast Adenocarcinoma","Metastatic Breast Carcinoma","Recurrent Breast Carcinoma","Recurrent Hodgkin Lymphoma","Recurrent Mycosis Fungoides","Recurrent Non-Hodgkin Lymphoma","Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory Breast Carcinoma","Refractory Hodgkin Lymphoma","Refractory Mycosis 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