Phase I/II Combination With Irinotecan- Erbitux

October 12, 2015 updated by: Bristol-Myers Squibb

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Local Institution
  • Denmark
      • Odense C, Denmark, 5000
        • Local Institution
  • Italy
      • Meldola Fc, Italy, 47014
        • Local Institution
      • Milano, Italy, 20141
        • Local Institution
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
  • Spain
      • Madrid, Spain, 28050
        • Local Institution
  • Sweden
      • Stockholm, Sweden, 17176
        • Local Institution
      • Uppsala, Sweden, 75185
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Usc/Norris Comprehensive Cancer Center Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 - Phase 1

Cetuximab + Irinotecan + Brivanib

OR

Cetuximab + Irinotecan + Brivanib Placebo
Drug: Cetuximab
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
Other Names:
  • Erbitux
  • BMS-564717
Drug: Irinotecan
IV solution, IV, Q3W, 350 mg/m2, until progression
Drug: Brivanib
Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
Drug: Brivanib
Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
Drug: Brivanib Placebo
Oral, tablet, QD, until progression
Placebo Comparator: Arm 2 - Phase 2

Cetuximab + Irinotecan + Brivanib

OR

Cetuximab + Irinotecan + Brivanib Placebo
Drug: Cetuximab
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
Other Names:
  • Erbitux
  • BMS-564717
Drug: Irinotecan
IV solution, IV, Q3W, 350 mg/m2, until progression
Drug: Brivanib
Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
Drug: Brivanib
Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
Drug: Brivanib Placebo
Oral, tablet, QD, until progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
Time Frame: PK C1D1-C2-D3, biomarker throughout the study
PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected
Time Frame: throughout the study on Part II
throughout the study on Part II

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects
Time Frame: throughout the study on Part II
throughout the study on Part II

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-025
  • 2007-005097-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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