NCT00502307

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Tivozanib (AV-951)	solid oral dosage form taken daily for three weeks per one month cycle
DRUG	Placebo comparator	solid oral capsule containing excipients dosed daily for three weeks per month

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-07-17
• Last updated: 2020-09-01
• Results posted: 2020-09-01

Locations

26 sites across 3 countries: India, Russia, Ukraine