Study of Tivozanib (AV-951) Plus FOLFOX6 in Subjects With Advanced Colorectal Cancer and Other Gastrointestinal Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Colorectal CancerGastrointestinal Cancer
Interventions
DRUG

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."

Trial Locations (2)

Unknown

University Medical Center Groningen; Internal Medicine, Department of Medical Oncology, Groningen

Erasmus Medical Center; Department of Medical Oncology, Rotterdam

Sponsors
All Listed Sponsors
lead

AVEO Pharmaceuticals, Inc.

INDUSTRY