Phase I/II Combination With Irinotecan- Erbitux

Metastatic Colorectal Cancer (MCRC) Clinical Trial

Official title:

A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594984
• Other study ID #: CA182-025
• Secondary ID: 2007-005097-31
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 7, 2008
• Last updated: October 12, 2015
• Start date: May 2008
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)

Part 2: To compare median duration of progression free survival (PFS)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy proven MCRC

• Prior irinotecan allowed

• Prior Erbitux allowed

Exclusion Criteria:

• No prior brivanib

• No prior combination of irinotecan with Erbitux

• No secondary malignancies

• No anti-coagulation therapy

• No prior history of blood clots requiring anti-coagulation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer (MCRC)

Intervention

Drug:
• Cetuximab
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
• Irinotecan
IV solution, IV, Q3W, 350 mg/m2, until progression
• Brivanib
Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
• Brivanib
Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
• Brivanib Placebo
Oral, tablet, QD, until progression

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Denmark	Local Institution	Odense C
Italy	Local Institution	Meldola Fc
Italy	Local Institution	Milano
Korea, Republic of	Local Institution	Seoul
Spain	Local Institution	Madrid
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
United States	Usc/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Usc/Norris Comprehensive Cancer Center Hospital	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Denmark,  Italy,  Korea, Republic of,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial		PK C1D1-C2-D3, biomarker throughout the study	No
Primary	Safety and tolerability of interventions will be collected		throughout the study on Part II	Yes
Secondary	Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects		throughout the study on Part II	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form