A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
Phase 1: Single Arm Study
Phase 2: Randomized Controlled, Parallel
Inclusion Criteria:
- Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or
metastatic colorectal cancer who have relapsed or are refractory to 2 or more
standard systemic anticancer regimes for metastatic disease, or are intolerant to
existing therapies.
- Histologic or cytologic confirmation of the diagnosis.
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Adequate organ & marrow function.
Exclusion Criteria:
- Uncontrolled or significant cardiovascular disease.
- Phase 2: Prior therapy with a RAF inhibitor.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Outcome Time Frame:
Assessments every 1-2 weeks while receiving study drug
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA206-001
NCT ID:
NCT01086267
Start Date:
July 2010
Completion Date:
August 2011
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
| Oncology Research Associates D/B/A | Scottsdale, Arizona 85258 |
