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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Cetuximab

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