Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With MEK (Mitogen-activated Protein Kinase) Inhibitor BAY86-9766 in Patients With Advanced Cancer
The PI3K (phosphoinositol 3-Kinase) inhibitor BAY80-6946 and the MEK (mitogen-activated protein kinase) inhibitor 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 BAY80-6946 and BAY86-9766 when given together at different/increasing dose levels?
- What dose level of BAY80-6946 and BAY86-9766 should be tested in future clinical research studies?
- How much BAY80-6946 is in the blood at specific times after administration and does adding BAY86-9766 have an affect?
- How much BAY86-9766 is in the blood at specific times after administration and does adding BAY80-6946 have an affect?
- Does the combination of BAY86-9766 and BAY80-6946 have an effect on tumors?
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Ib Trial of the Combination of PI3K Inhibitor BAY80-6946 and Allosteric-MEK Inhibitor BAY86-9766 in Subjects With Advanced Cancer|
- Maximum Tolerated Dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Comparison of the BAY80-6946 AUC when given alone with the AUC when given with BAY86-9766 [ Time Frame: At day 15 ] [ Designated as safety issue: No ]
- Comparison of the BAY86-9766 AUC when given alone with the AUC when given with BAY80-6946 [ Time Frame: At day 15 ] [ Designated as safety issue: No ]
- Tumor Response as measured by RECIST 1.1 criteria [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Biomarker evaluation including analysis of pathway activation in blood and plasma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Tumor Response as measured by FDG-PET at MTD and expansion cohort(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Pharmacodynamic biomarker evaluation analysis using paired tumor biopsies [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Drug: BAY80-6946 + BAY86-9766
BAY80-6946 will be administered as an IV infusion weekly for 3 weeks in combination with BAY86-9766 at varying dose levels. BAY86-9766 is administered orally twice a day starting at Day 4 of Cycle 1.Drug: BAY80-6946 + BAY86-9766
BAY80-6946 will be administered as an IV infusion weekly in combination with BAY86-9766 at varying dose levels. BAY86-9766 is administered orally twice a day starting at Day 6 of Cycle 1 on a 4 day on, 3 day off schedule.
|Contact: Bayer Clinical Trials Contactfirstname.lastname@example.org|
|Contact: For trial location information (Phone Menu Options '3' or '4')||(+)1-888-84 22937|
|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|