drugset / Trial / NCT01030783

A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

NCT01030783

Phase 3 Completed 517 enrolled AVEO Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.

Timeline

Start
2009-12
Primary completion
2012-07
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sorafenib Small molecule 400 mg Oral
Subject Tivozanib Small molecule 1.5 mg Oral

Indications