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CLINICAL TRIALS PROFILE FOR COPANLISIB DIHYDROCHLORIDE

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Clinical Trials for Copanlisib Dihydrochloride

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.

Clinical Trial Conditions for Copanlisib Dihydrochloride

Condition Name

Condition Name for Copanlisib Dihydrochloride
Intervention	Trials
Estrogen Receptor Positive	3
Lymphoma, Non-Hodgkin	3
HER2/Neu Negative	3

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Condition MeSH

Condition MeSH for Copanlisib Dihydrochloride
Intervention	Trials
Lymphoma	16
Lymphoma, Non-Hodgkin	8
Carcinoma	6

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Clinical Trial Locations for Copanlisib Dihydrochloride

Trials by Country

Trials by Country for Copanlisib Dihydrochloride
Location	Trials
United States	68
China	21
Germany	18
Italy	15
Australia	10

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Trials by US State

Trials by US State for Copanlisib Dihydrochloride
Location	Trials
New York	7
California	5
Texas	5
Maryland	5
New Jersey	5

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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	7
Phase 1/Phase 2	11

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Clinical Trial Status

Clinical Trial Status for Copanlisib Dihydrochloride
Clinical Trial Phase	Trials
Recruiting	18
Not yet recruiting	12
Completed	4

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Clinical Trial Sponsors for Copanlisib Dihydrochloride

Sponsor Name

Sponsor Name for Copanlisib Dihydrochloride
Sponsor	Trials
Bayer	22
National Cancer Institute (NCI)	10
Memorial Sloan Kettering Cancer Center	2

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Sponsor Type

Sponsor Type for Copanlisib Dihydrochloride
Sponsor	Trials
Industry	23
Other	15
NIH	10

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