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CLINICAL TRIALS PROFILE FOR COPANLISIB DIHYDROCHLORIDE

Clinical Trials for Copanlisib Dihydrochloride

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Trial ID	Title	Status	Sponsor	Phase	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	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	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	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	Active, not recruiting	Bayer	Phase 1	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 Patients	Recruiting	Bayer	Phase 1	In summary, copanlisib is metabolized mainly by the CYP3A4 enzyme, thus a study to evaluate potential DDI (drug-drug interaction) of copanlisib with concomitant CYP3A4 modulators such as Itraconazole (CYP3A4 inhibitor) and Rifampin (CYP3A4 inducer) is necessary. With this regard this study aims to evaluate the effect of Itraconazole or Rifampin on the absorbtion, distribution, metabolization and elimination of Copanlisib (BAY80-6946) . In addition, as parameters of cardiovascular safety , the effect of copanlisib on the heart's ability to pump blood and to rule out copanlisib's potential for causing a specific type of life-threatening arrhythmia, QT/QTc intervals and left ventricular ejection fraction will be evaluated.
NCT02342665	Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL	Recruiting	Bayer	Phase 1/Phase 2	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
Trial ID	Title	Status	Sponsor	Phase	Summary