30
Participants
Start Date
June 30, 2008
Primary Completion Date
June 30, 2012
Study Completion Date
June 30, 2012
Tivozanib (AV-951) plus FOLFOX6
"Investigational product, dosage and mode of administration (1 cycle = 4 weeks of treatment):~Tivozanib (AV-951): 0.5 mg, 1.0 mg, and 1.5 mg oral once daily On Day -5 (± 2 days) subjects will receive a single dose of tivozanib (AV-951) for pharmacokinetic sampling. Beginning on Day 1 of Cycle 1, subjects will receive tivozanib (AV-951) once daily for 3 weeks followed by 1 week off. Tivozanib (AV-951) dosing repeats every cycle in the absence of disease progression or unacceptable toxicity. On days when both tivozanib (AV-951) and the FOLFOX6 chemotherapy regimen are co-administered, tivozanib (AV-951) will be administered immediately prior to the start of the FOLFOX6 chemotherapy regimen.~Subjects will receive FOLFOX6 chemotherapy every 2 weeks starting on Day 1 of Cycle 1. Subjects will receive 2 treatments of FOLFOX6 in each treatment cycle, starting on Day 1 and Day 15."
University Medical Center Groningen; Internal Medicine, Department of Medical Oncology, Groningen
Erasmus Medical Center; Department of Medical Oncology, Rotterdam
Lead Sponsor
AVEO Pharmaceuticals, Inc.
INDUSTRY