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. |
| >Trial ID | >Title | >Status | >Sponsor | >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 |
| Refractory Malignant Solid Neoplasm | 4 |
| [disabled in preview] | 0 |
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