The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity
IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity
IV solution, IV infusion over 46 hours, 2400 mg/m², Every 14 days, Until disease progression/toxicity
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Texas Oncology
Dallas, Texas, United States
Scott & White Memorial Hospital And Clinic
Temple, Texas, United States
Local Institution
Edmonton, Alberta, Canada
Safety-Toxicity, evaluated according to NCI Common Terminology Criteria for Adverse Events v3.0. Assessments based on medical review of adverse events, results of vital signs, ECGs, echocardiography, physical examinations, and clinical laboratory tests
Time frame: Cycle 4, Day 1
Pharmacokinetics (Cmax, Tmax, AUC (TAU), T-HALF) plasma concentration vs time for brivanib given alone and in combination with FOLFIRI. Individual concentrations (C) of 5FU will be calculated from samples on Day 2 in the presence and absence of Brivanib
Time frame: Cycle 2, Day 2
Efficacy-Tumor BOR determined for treated subjects by radiological responses assessed by CT scan or MRI, by RECIST criteria (v1.1). Radiological tumor assessments to evaluate response & progression will be done every 8 wks or more frequently if indicated
Time frame: Every 8 weeks
Exploratory Measures (Biomarkers for Predictive Analysis): Potential predictive markers, including activity of FGF, VEGF and related pathways as well as K-RAS mutation status, will be evaluated based on blood or tumor samples
Time frame: Cycle 1, Cycle 2, every other cycle
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IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity
Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity
Tablets, Oral, 600 - 800 mg, once daily, Until disease progression/toxicity
Tablets, Oral, 800 mg, once daily, Until disease progression/toxicity
Local Institution
Ottawa, Ontario, Canada
Local Institution
Villejuif, France