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?
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.
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.
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