Who is sponsoring NCT00207051?

NCT00207051 is sponsored by Bristol-Myers Squibb.

What condition does NCT00207051 study?

NCT00207051 studies Colorectal Cancer.

What drugs are being tested in NCT00207051?

Interventions: Brivanib + Cetuximab.

What is the status of NCT00207051?

NCT00207051 is currently COMPLETED.

Last reviewed 2011-01-24 · How we verify

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

NCT00207051 Phase 1 COMPLETED

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.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	COMPLETED
Enrolment	62
Start date	2006-01
Completion	2008-12

Conditions

Colorectal Cancer

Interventions

Brivanib + Cetuximab

Primary outcomes

Safety assessment — throughout the study
dose limiting toxicity (DLT) — 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) — 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

Countries

United States, Canada, Netherlands