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

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.

We found this trial at

sites

Local Institution

Ottawa, Ontario

from

Ottawa,