Phase I/II Combination With Irinotecan- Erbitux

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Colorectal Cancer (MCRC)

Treatments: Drug: Brivanib; Drug: Brivanib Placebo; Drug: Irinotecan; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00594984

CA182-025

2007-005097-31

Details and patient eligibility

About

Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)

Part 2: To compare median duration of progression free survival (PFS)

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven MCRC
• Prior irinotecan allowed
• Prior Erbitux allowed

Exclusion criteria

• No prior brivanib
• No prior combination of irinotecan with Erbitux
• No secondary malignancies
• No anti-coagulation therapy
• No prior history of blood clots requiring anti-coagulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Arm 1 - Phase 1

Active Comparator group

Description:

Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Treatment:

Drug: Cetuximab

Drug: Brivanib

Drug: Irinotecan

Drug: Brivanib Placebo

Drug: Brivanib

Arm 2 - Phase 2

Placebo Comparator group

Description:

Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Treatment:

Drug: Cetuximab

Drug: Brivanib

Drug: Irinotecan

Drug: Brivanib Placebo

Drug: Brivanib