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
|ClinicalTrials.gov Identifier: NCT01392521|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 17, 2015
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:
- What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels?
- What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies?
- How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect?
- How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect?
- Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors?
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Copanlisib + Refametinib (BAY86-9766)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2011|
|Primary Completion Date :||February 2014|
|Study Completion Date :||April 2014|
|Experimental: Arm 1||
Drug: Copanlisib + Refametinib (BAY86-9766)
Copanlisib will be administered as an IV infusion weekly for 3 weeks in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 4 of Cycle 1.Drug: Copanlisib + Refametinib (BAY86-9766)
Copanlisib will be administered as an IV infusion weekly in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 6 of Cycle 1 on a 4 day on, 3 day off schedule.
- Maximum Tolerated Dose [ Time Frame: 2 years ]
- Comparison of the Copanlisib AUC when given alone with the AUC when given with Refametinib (BAY86-9766) [ Time Frame: At day 15 ]
- Comparison of the Refametinib (BAY86-9766) AUC when given alone with the AUC when given with Copanlisib [ Time Frame: At day 15 ]
- Tumor Response as measured by RECIST 1.1 criteria [ Time Frame: 3 years ]
- Biomarker evaluation including analysis of pathway activation in blood and plasma [ Time Frame: 3 years ]
- Tumor Response as measured by FDG-PET at MTD and expansion cohort(s) [ Time Frame: 3 years ]
- Pharmacodynamic biomarker evaluation analysis using paired tumor biopsies [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392521
|United States, Arizona|
|Scottsdale, Arizona, United States, 85260|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89169|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29605|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Tyler, Texas, United States, 75702|
|United States, Washington|
|Vancouver, Washington, United States, 98684|
|Freiburg, Baden-Württemberg, Germany, 79106|
|Rotterdam, Netherlands, 3015 CE|
|Study Director:||Bayer Study Director||Bayer|