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

Completed · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

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

Key facts

Study ID

NCT01086267

Run by

Bristol-Myers Squibb

People needed

17

Starts

2010-07-01

Expected to finish

2011-08-01

Last updated by the study team

2016-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Uncontrolled or significant cardiovascular disease.
• Phase 2: Prior therapy with a RAF inhibitor.

Where it is running

• Oncology Research Associates D/B/A — Scottsdale, Arizona, United States
• Usc Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Local Institution — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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