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 Gastrointestinal Malignancies Who Have Failed Prior Therapy
Overview
- Phase
- Phase 1
- Intervention
- Brivanib + Cetuximab
- Conditions
- Colorectal Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 62
- Locations
- 6
- Primary Endpoint
- Safety assessment
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: Brivanib + Cetuximab
Outcomes
Primary Outcomes
Safety assessment
Time Frame: throughout the study
dose limiting toxicity (DLT)
Time Frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Time Frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximu tolerated dose is identified
Secondary Outcomes
- Efficacy based on duration of response and time to progression based on assessment(Measured every 8 weeks throughout the study)