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Phase I/II Combination With Irinotecan- Erbitux

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00594984
Collaborator
(none)
38
Enrollment
12
Locations
2
Arms
55
Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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 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, MTD determined in Arm 1, Phase 1, until progression

    Drug: Brivanib Placebo
    Oral, tablet, QD, until progression

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial [PK C1D1-C2-D3, biomarker throughout the study]

    2. Safety and tolerability of interventions will be collected [throughout the study on Part II]

    Secondary Outcome Measures

    1. Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects [throughout the study on Part II]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Usc/Norris Comprehensive Cancer Center Hospital Los Angeles California United States 90033
    2 Usc/Norris Comprehensive Cancer Center Los Angeles California United States 90033
    3 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    4 Washington University Saint Louis Missouri United States 63110
    5 Local Institution Buenos Aires Argentina C1426ANZ
    6 Local Institution Odense C Denmark 5000
    7 Local Institution Meldola Fc Italy 47014
    8 Local Institution Milano Italy 20141
    9 Local Institution Seoul Korea, Republic of 135-710
    10 Local Institution Madrid Spain 28050
    11 Local Institution Stockholm Sweden 17176
    12 Local Institution Uppsala Sweden 75185

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00594984
    Other Study ID Numbers:
    • CA182-025
    • 2007-005097-31
    First Posted:
    Jan 16, 2008
    Last Update Posted:
    Nov 4, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Irinotecan
    Cetuximab

    Study Results

    No Results Posted as of Nov 4, 2015