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

Summary

The FOLFOX6 regimen is a standard chemotherapy regimen for the treatment of patients with colorectal cancer and other gastrointestinal cancers. Tivozanib (AV-951) is a targeted anti-angiogenesis agent that has demonstrated acceptable tolerability in a phase I clinical trial. This study is designed to test the hypothesis that tivozanib (AV-951) can be combined with standard FOLFOX6 chemotherapy for the treatment of patients with colorectal and other gastrointestinal cancers. The purpose of this study is to determine the maximum dose of tivozanib (AV-951) that can be safely combined with FOLFOX6 chemotherapy, and to evaluate the safety profile, tolerability, and pharmacokinetics of this combination.

Timeline

Start

2008-06

Primary completion

2012-06

Completion

2012-06

Publications

• Oldenhuis CN, Loos WJ, Esteves B, van Doorn L, Cotreau MM, Strahs AL, den Hollander MW, Gietema JA, de Vries EG, Eskens FA. A phase Ib study of the VEGF receptor tyrosine kinase inhibitor tivozanib and modified FOLFOX-6 in patients with advanced gastrointestinal malignancies. Clin Colorectal Cancer. 2015 Mar;14(1):18-24.e1. doi: 10.1016/j.clcc.2014.12.001. Epub 2014 Dec 16.

Drugs

Indications