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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR COPANLISIB DIHYDROCHLORIDE


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All Clinical Trials for Copanlisib Dihydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01392521 ↗ Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer Completed Bayer Phase 1 2011-07-01 The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions: 1. What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels? 2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies? 3. How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect? 4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect? 5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors?
NCT01460537 ↗ Phase 1 Study of PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib With Gemcitabine or Cisplatin Plus Gemcitabine in Patients With Advanced Cancer Completed Bayer Phase 1 2011-11-18 This open label Phase I study involves treating subjects with advanced cancer with Copanlisib in combination with either gemcitabine or cisplatin plus gemcitabine. It will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib in combination with gemcitabine and Copanlisib in combination with cisplatin and gemcitabine. The trial will involve multiple participating sites from the US. Up to a maximum of 70 subjects will be enrolled in the study.
NCT02119221 ↗ Copanlisib Mass Balance Study Completed Bayer Phase 1 2014-02-01 The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
NCT02155582 ↗ Copanlisib Pharmacodynamic Study Completed Bayer Phase 1 2014-08-12 This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.
NCT02253420 ↗ COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients Completed Bayer Phase 1 2014-10-08 To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946). To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
NCT02342665 ↗ Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL Active, not recruiting Bayer Phase 1/Phase 2 2015-04-21 The primary objective of this study is to assess the safety profile of copanlisib at the recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients will be determined in the dose escalation/safety evaluation part.
NCT02367040 ↗ Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) Active, not recruiting Bayer Phase 3 2015-08-03 The purpose of this study is to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Copanlisib Dihydrochloride

Condition Name

Condition Name for Copanlisib Dihydrochloride
Intervention Trials
Metastatic Breast Carcinoma 6
Anatomic Stage IV Breast Cancer AJCC v8 5
Metastatic Malignant Solid Neoplasm 5
Prognostic Stage IV Breast Cancer AJCC v8 4
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Condition MeSH

Condition MeSH for Copanlisib Dihydrochloride
Intervention Trials
Lymphoma 32
Carcinoma 13
Lymphoma, Non-Hodgkin 12
Breast Neoplasms 11
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Clinical Trial Locations for Copanlisib Dihydrochloride

Trials by Country

Trials by Country for Copanlisib Dihydrochloride
Location Trials
United States 213
China 30
Japan 28
Italy 26
Germany 23
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Trials by US State

Trials by US State for Copanlisib Dihydrochloride
Location Trials
Texas 16
New York 14
California 12
Massachusetts 10
New Jersey 9
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Clinical Trial Progress for Copanlisib Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Copanlisib Dihydrochloride
Clinical Trial Phase Trials
Phase 3 3
Phase 2 17
Phase 1/Phase 2 17
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Clinical Trial Status

Clinical Trial Status for Copanlisib Dihydrochloride
Clinical Trial Phase Trials
Recruiting 27
Active, not recruiting 13
Completed 11
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Clinical Trial Sponsors for Copanlisib Dihydrochloride

Sponsor Name

Sponsor Name for Copanlisib Dihydrochloride
Sponsor Trials
Bayer 33
National Cancer Institute (NCI) 21
Memorial Sloan Kettering Cancer Center 3
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Sponsor Type

Sponsor Type for Copanlisib Dihydrochloride
Sponsor Trials
Other 48
Industry 39
NIH 21
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