A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer (MCRC)
Both
Metastatic Colorectal Cancer (MCRC)
Trial Information
A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
Inclusion Criteria:
- Biopsy proven MCRC
- Prior irinotecan allowed
- Prior Erbitux allowed
Exclusion Criteria:
- No prior brivanib
- No prior combination of irinotecan with Erbitux
- No secondary malignancies
- No anti-coagulation therapy
- No prior history of blood clots requiring anti-coagulation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
Outcome Time Frame:
PK C1D1-C2-D3, biomarker throughout the study
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA182-025
NCT ID:
NCT00594984
Start Date:
May 2008
Completion Date:
December 2012
Related Keywords:
- Metastatic Colorectal Cancer (MCRC)
- Colorectal Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Washington University | St. Louis, Missouri 63110 |
| Usc/Norris Comprehensive Cancer Center Hospital | Los Angeles, California 90033 |
