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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
IV solution, IV, Q3W, 350 mg/m2, until progression
Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
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
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
Time frame: PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected
Time frame: throughout the study on Part II
Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects
Time frame: throughout the study on Part II
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Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
Oral, tablet, QD, until progression
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
...and 2 more locations