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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Cetuximab; Drug: BMS-908662

Study type: Interventional

Funder types: Industry

Identifiers

NCT01086267

2010-018944-15 (EudraCT Number)

CA206-001

Details and patient eligibility

About

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

Full description

Phase 1: Single Arm Study

Phase 2: Randomized Controlled, Parallel

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 4 patient groups

BMS-908662 (A1)

Experimental group

Description:

Phase 1

Treatment:

Drug: BMS-908662

Drug: BMS-908662

Cetuximab (A1)

Experimental group

Description:

Phase 1

Treatment:

Drug: Cetuximab

BMS-908662 (B1)

Experimental group

Description:

Phase 2

Treatment:

Drug: BMS-908662

Drug: BMS-908662

BMS-908662 + Cetuximab (B2)

Experimental group

Description:

Phase 2

Treatment:

Drug: BMS-908662

Drug: BMS-908662

Drug: Cetuximab