NCT00660153

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

A Phase 1b, Open-Label, Dose-Escalation Study of Tivozanib (AV-951) Plus FOLFOX6 in Subjects With Advanced Colorectal Cancer and Other Gastrointestinal Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1b, open-label, study design that will examine safety, tolerability, and maximum tolerated dose of tivozanib (AV-951) and FOLFOX6 in advanced colorectal cancer and other gastrointestinal cancers. In the study, only the doses of tivozanib (AV-951) will be escalated from 0.5 mg/day to 1.5 mg/day. All subjects will receive standard doses of FOLFOX6 chemotherapy every 2 weeks.

Conditions

• Colorectal Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-04-17
• Last updated: 2012-08-28

Locations

2 sites across 1 country: Netherlands