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

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Brivanib + Cetuximab

• Registration Number: NCT00207051
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Study Start: 2006-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Brivanib + Cetuximab	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Efficacy based on duration of response and time to progression based on assessment	Measured every 8 weeks throughout the study

Trial Locations

Locations (6)

Usc/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Georgetn Univ Lombardi Can Ctr; 🇺🇸 Washington, District of Columbia, United States

University Of Miami Miller School Of Medicine; 🇺🇸 Miami, Florida, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Local Institution; 🇳🇱 Amsterdam, Netherlands