Copanlisib

Generic Name: Copanlisib

Brand Names: Aliqopa

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₈N_₈O_₄

CAS Number: 1032568-63-0

Unique Ingredient Identifier: WI6V529FZ9

Background: Copanlisib is a selective pan-Class I phosphoinositide 3-kinase (PI3K) inhibitor with preferential activity against the alpha and delta isoforms. PI3K, a lipid kinase that activates downstream signalling pathways involved in cell survival and growth, that exists in different isoforms and is often overexpressed in hematological malignancies. Copanlisib was gr...

Indication: Copanlisib is indicated for the treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. This indication was granted under accelerated approval; thus, continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Associated Conditions: Relapsed Follicular Lymphoma

Associated Therapies: -

Clinical Trials

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

Phase 1

Terminated

Conditions: Anatomic Stage IV Breast Cancer AJCC v8
HER2-Positive Breast Carcinoma
Metastatic Breast Carcinoma

Interventions: Drug: Copanlisib
Biological: Trastuzumab
Biological: Pertuzumab

First Posted Date: 2019-09-30

Last Posted Date: 2024-06-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2

Registration Number: NCT04108858

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

and more 2 locations

Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Phase 1

Terminated

Conditions: Metastatic Breast Cancer
Locally Advanced Breast Cancer
HER2-positive Breast Cancer
Unresectable Breast Cancer

Interventions: Drug: Copanlisib
Drug: Trastuzumab emtansine

First Posted Date: 2019-08-01

Last Posted Date: 2023-04-06

Lead Sponsor: Cancer Trials Ireland

Target Recruit Count: 2

Registration Number: NCT04042051

Locations: 🇪🇸
Cancer Trials Ireland Investigative Site, Seville, Spain

Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

Phase 1

Terminated

Conditions: Non-Hodgkin Lymphoma

Interventions: Drug: Copanlisib
Drug: Venetoclax

First Posted Date: 2019-03-22

Last Posted Date: 2022-04-01

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 7

Registration Number: NCT03886649

Locations: 🇨🇭
Universitaetsspital Basel, Basel, Switzerland
🇨🇭
Hôpitaux Universitaires de Genève, Genève, Switzerland
🇨🇭
Kantonsspital St. Gallen, St. Gallen, Switzerland

and more 3 locations

Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
Indolent Non-Hodgkin Lymphoma
Lymphoplasmacytic Lymphoma
Marginal Zone Lymphoma
Richter Syndrome

Interventions: Drug: Copanlisib
Biological: Nivolumab

First Posted Date: 2019-03-21

Last Posted Date: 2024-08-05

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 27

Registration Number: NCT03884998

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
City of Hope Medical Center, Duarte, California, United States

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1

Terminated

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma

Interventions: Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat

First Posted Date: 2019-03-18

Last Posted Date: 2024-03-04

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 2

Registration Number: NCT03878524

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

Phase 1

Completed

Conditions: Mantle Cell Lymphoma (MCL)

Interventions: Drug: Copanlisib
Drug: Ibrutinib

First Posted Date: 2019-03-15

Last Posted Date: 2022-12-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 8

Registration Number: NCT03877055

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States

and more 3 locations

A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer

Phase 1

Withdrawn

Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Prognostic Stage IV Breast Cancer AJCC v8

Interventions: Drug: Copanlisib
Drug: Fulvestrant

First Posted Date: 2019-01-15

Last Posted Date: 2023-09-25

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT03803761

Locations: 🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
University of Texas Medical Branch, Galveston, Texas, United States
🇺🇸
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

and more 4 locations

Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma

Phase 2

Active, not recruiting

Conditions: Follicular Lymphoma
Non-Hodgkin's Lymphoma
NHL

Interventions: Biological: Rituximab
Drug: Copanlisib

First Posted Date: 2018-12-28

Last Posted Date: 2024-12-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 22

Registration Number: NCT03789240

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)
Hepatocellular Carcinoma (HCC)
Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions: Drug: Copanlisib
Drug: Nivolumab

First Posted Date: 2018-11-08

Last Posted Date: 2023-10-06

Lead Sponsor: Bayer

Target Recruit Count: 16

Registration Number: NCT03735628

Locations: 🇺🇸
Rocky Mountain Cancer Centers / Denver, CO, Denver, Colorado, United States
🇺🇸
Tower Hematology/Oncology Medical Group, Beverly Hills, California, United States
🇺🇸
Orthopaedic Institute for Children, Los Angeles, California, United States

and more 3 locations

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

Phase 1

Active, not recruiting

Conditions: Colon Cancer
Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor Along With Microsatellite Stable (MSS) Colon Cancer

Interventions: Drug: Copanlisib
Drug: Nivolumab

First Posted Date: 2018-10-18

Last Posted Date: 2024-01-05

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 48

Registration Number: NCT03711058

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Drug Development Updates

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