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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/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

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 CenterLos Angeles, California  90089
Oncology Research Associates D/B/AScottsdale, Arizona  85258