Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF
|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-582664Drug: Irinotecan
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.
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|