A Phase 1 interventional study of Brivanib + Cetuximab in Colorectal Cancer, sponsored by Bristol-Myers Squibb. Completed at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-25.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 62 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.
Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: Brivanib + Cetuximab
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
Efficacy based on duration of response and time to progression based on assessment
Time frame: Measured every 8 weeks throughout the study
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Brivanib · Cetuximab