Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2010 |
| End Date: | August 2011 |
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
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in
combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when
administered alone or in combination with cetuximab
combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when
administered alone or in combination with cetuximab
Phase 1: Single Arm Study
Phase 2: Randomized Controlled, Parallel
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.
We found this trial at
3
sites
1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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