Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2008-05-31
2012-12-31
Brief Summary
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Part 2: To compare median duration of progression free survival (PFS)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
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 Placebo
Oral, tablet, QD, until progression
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo
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, MTD determined in Arm 1, Phase 1, until progression
Brivanib Placebo
Oral, tablet, QD, until progression
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior irinotecan allowed
* Prior Erbitux allowed
Exclusion Criteria
* No prior combination of irinotecan with Erbitux
* No secondary malignancies
* No anti-coagulation therapy
* No prior history of blood clots requiring anti-coagulation
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Usc/Norris Comprehensive Cancer Center Hospital
Los Angeles, California, United States
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Washington University
St Louis, Missouri, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Odense C, , Denmark
Local Institution
Meldola Fc, , Italy
Local Institution
Milan, , Italy
Local Institution
Seoul, , South Korea
Local Institution
Madrid, , Spain
Local Institution
Stockholm, , Sweden
Local Institution
Uppsala, , Sweden
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2007-005097-31
Identifier Type: -
Identifier Source: secondary_id
CA182-025
Identifier Type: -
Identifier Source: org_study_id
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