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 granted accelerated approval by the FDA in September 2017 for the treatment of follicular lymphoma.

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

Copanlisib and Rituximab in Marginal Zone Lymphoma Patients

Phase 2

Active, not recruiting

Conditions: Marginal Zone Lymphoma

Interventions: Drug: Copanlisib
Drug: Rituximab

First Posted Date: 2018-03-23

Last Posted Date: 2023-08-25

Lead Sponsor: Christian Buske

Target Recruit Count: 36

Registration Number: NCT03474744

Locations: 🇦🇹
Med. Uni Wien AKH, Klinische Abteilung für Onkologie, Innere Medizin I, Wien, Austria
🇩🇪
St. Josef-Hospital, Medizinische Klinik I, Bochum, Germany
🇩🇪
Johanniter GmbH, Johanniter-Krankenhaus, Bonn, Germany

and more 15 locations

Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

Phase 2

Withdrawn

Conditions: Estrogen Receptor Positive
HER2/Neu Negative
Progesterone Receptor Positive
Stage IV Breast Cancer AJCC v6 and v7

Interventions: Drug: Fulvestrant
Drug: Copanlisib
Other: Laboratory Biomarker Analysis
Drug: Palbociclib

First Posted Date: 2017-12-19

Last Posted Date: 2018-08-14

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT03377101

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Phase 1

Terminated

Conditions: Invasive Breast Carcinoma
Stage II Breast Cancer
Stage IIA Breast Cancer
Estrogen Receptor Positive
HER2/Neu Negative
Multifocal Breast Carcinoma
Postmenopausal
Progesterone Receptor Positive
Stage I Breast Cancer
Stage IA Breast Cancer

Interventions: Drug: Copanlisib
Procedure: Biopsy of Breast
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Pharmacological Study
Drug: Palbociclib

First Posted Date: 2017-04-25

Last Posted Date: 2022-09-26

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 10

Registration Number: NCT03128619

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Copanlisib and Gemcitabine in Relapsed/Refractory PTCL

Phase 1

Completed

Conditions: Mature T-Cell and NK-Cell Neoplasm

Interventions: Drug: Copanlisib
Drug: Gemcitabine

First Posted Date: 2017-02-14

Last Posted Date: 2022-06-10

Lead Sponsor: Chonnam National University Hospital

Target Recruit Count: 28

Registration Number: NCT03052933

Locations: 🇰🇷
Chonnam National University Hwasun Hospital, Hwasun-gun, Jeollanam-do, Korea, Republic of

Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss

Phase 1

Terminated

Conditions: Carcinoma, Squamous Cell of Head and Neck

Interventions: Drug: Copanlisib
Drug: Cetuximab

First Posted Date: 2016-07-04

Last Posted Date: 2021-03-29

Lead Sponsor: UNICANCER

Target Recruit Count: 11

Registration Number: NCT02822482

Locations: 🇫🇷
Institut de Cancérologie de l'Ouest, Angers, France
🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
Centre Georges François Leclerc, Dijon, France

and more 4 locations

Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Endometrioid Adenocarcinoma
Endometrial Mixed Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Endometrial Undifferentiated Carcinoma
Metastatic Endometrioid Adenocarcinoma
Recurrent Uterine Corpus Cancer

Interventions: Drug: Copanlisib
Other: Laboratory Biomarker Analysis

First Posted Date: 2016-04-05

Last Posted Date: 2022-02-15

Lead Sponsor: NRG Oncology

Target Recruit Count: 11

Registration Number: NCT02728258

Locations: 🇺🇸
The Mark H Zangmeister Center, Columbus, Ohio, United States
🇺🇸
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

and more 40 locations

Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study)

Phase 1

Completed

Conditions: HER2 Positive Breast Cancer

Interventions: Drug: Copanlisib
Drug: Trastuzumab

First Posted Date: 2016-03-11

Last Posted Date: 2025-01-09

Lead Sponsor: Cancer Trials Ireland

Target Recruit Count: 26

Registration Number: NCT02705859

Locations: 🇮🇪
Cancer Trials Ireland Investigative Site, Galway, Ireland

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Phase 2

Completed

Conditions: Cholangiocarcinoma
Gastrointestinal Tumor
Biliary Carcinoma
Gall Bladder Carcinoma

Interventions: Drug: Cisplatin
Drug: Gemcitabine
Drug: Copanlisib

First Posted Date: 2015-12-16

Last Posted Date: 2021-08-04

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 24

Registration Number: NCT02631590

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma

Phase 1

Terminated

Conditions: Lymphoma, T-Cell, Peripheral

Interventions: Drug: MK-3475
Drug: Copanlisib

First Posted Date: 2015-08-28

Last Posted Date: 2022-07-08

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 17

Registration Number: NCT02535247

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Breast Carcinoma
Cervical Carcinoma
Liver Carcinoma
Malignant Uterine Neoplasm
Recurrent Gastric Carcinoma
Recurrent Head and Neck Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Afatinib
Drug: Binimetinib
Drug: Adavosertib
Drug: Capivasertib
Drug: Afatinib Dimaleate
Procedure: Biospecimen Collection
Other: Cytology Specimen Collection Procedure
Drug: Dabrafenib
Drug: Fexagratinib
Drug: Dasatinib
Drug: Ipatasertib
Drug: Defactinib
Drug: Sapanisertib
Procedure: Biopsy
Drug: Crizotinib
Drug: Dabrafenib Mesylate
Drug: PI3K-beta Inhibitor GSK2636771
Drug: Defactinib Hydrochloride
Drug: Palbociclib
Biological: Nivolumab
Drug: Copanlisib
Drug: Taselisib
Drug: Ulixertinib
Drug: Copanlisib Hydrochloride
Biological: Trastuzumab Emtansine
Biological: Relatlimab
Procedure: Computed Tomography
Drug: Trametinib
Biological: Pertuzumab
Drug: Erdafitinib
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Drug: Larotrectinib
Drug: Larotrectinib Sulfate
Procedure: Echocardiography
Drug: Osimertinib
Biological: Trastuzumab
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Vismodegib
Drug: Sunitinib Malate
Procedure: Radionuclide Imaging

First Posted Date: 2015-06-08

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6452

Registration Number: NCT02465060

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Thomas Hospital, Fairhope, Alabama, United States
🇺🇸
Mobile Infirmary Medical Center, Mobile, Alabama, United States

and more 1416 locations

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