BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Brivanib + Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207051

CA182-003

Details and patient eligibility

About

This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of advanced or metastatic (tumor has spread) gastrointestinal malignancy
• Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
• Available tumor tissue sample from prior surgery
• Measurable disease on scans
• 4-6 weeks since prior therapy and recovered from the effects of prior therapy
• Men and women, ages 18 and above
• Women must not be pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Brivanib + Cetuximab