Neoplasms Clinical Trial
Official title:
Phase Ib Trial of the Combination of PI3K Inhibitor BAY 80-6946 and Allosteric-MEK Inhibitor BAY 86-9766 in Subjects With Advanced Cancer
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?
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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