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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207051
• Other study ID #: CA182-003
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: January 24, 2011
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• Brivanib + Cetuximab
Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks

Locations

Country	Name	City	State
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Toronto	Ontario
Netherlands	Local Institution	Amsterdam
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Usc/Norris Comprehensive Cancer Center	Los Angeles	California
United States	University Of Miami Miller School Of Medicine	Miami	Florida
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Georgetn Univ Lombardi Can Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment		throughout the study	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Efficacy based on duration of response and time to progression based on assessment		Measured every 8 weeks throughout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form