Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01367275|
Recruitment Status : Terminated (Sponsor closed study)
First Posted : June 7, 2011
Last Update Posted : January 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Adenocarcinoma||Drug: Brivanib Drug: Irinotecan||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Second-line Irinotecan Plus Brivanib, a Dual Tyrosine Inhibitor of VEGFR and FGFR, in Metastatic Colorectal Cancer Patients Enriched for Elevated Levels of Plasma FGF Following Progression on Bevacizumab-based Treatment|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Brivanib + Irinotecan
Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m^2 on Day 1.
800 mg (4 x 200 mg tablets) self-administered orally at approximate same time each day on a continuous daily schedule Days 1-14 of 14 day cycle.
Other Name: BMS-582664
180 mg/m^2 by vein on Day 1 of a 14 day cycle.
- Progression-Free Survival (PFS) [ Time Frame: Enrollment (baseline) to disease progression or death, followed each 14 day treatment then every 2 months. ]Progression-free survival (PFS) is defined as the time from study enrollment to disease progression or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367275
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman, MD||UT MD Anderson Cancer Center|