A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title: A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma

Status Completed

Clinical Trial Summary

This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.

Clinical Trial Description

Approximately 200 patients will be enroled into the initial, 16 week, open-label period using 1.5 mg/day dosing. Patients will receive tivozanib (AV-951) continuously for 3 weeks followed by 1 week off study drug. Patients will undergo disease assessment at baseline and after Cycles 2 and 4 and response will be determined by RESIST criteria.

After the initial, 16 week open-label period, disease status will be assessed and compared to baseline using modified RECIST criteria:

• Patients with greater than or equal to 25% tumor shrinkage will continue on their current dose of tivozanib (AV-951)

• Patients with less than 25% tumor change (growth or shrinkage) will be randomly assigned to double-blind tivozanib (AV-951) or matching placebo for 12 weeks

• Patients with greater than or equal to 25% tumor growth will be discontinued ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

• NCT number: NCT00502307
• Study type: Interventional
• Source: AVEO Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Completion date: August 2010