CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 517 enrolled
Drug / intervention
tivozanib (AV-951) +1 moredrug
Likely dose
tivozanib (AV-951) 1.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01030783
NCT01030783Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

AVEO Pharmaceuticals, Inc.·interventional·Posted Dec 11, 2009·Updated Oct 28, 2019

In Brief

A Phase 3 clinical trial evaluating tivozanib (AV-951) and Sorafenib for Advanced Renal Cell Carcinoma. Completed, enrolled 517 participants across 86 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Renal Cell Carcinoma
CountriesArgentina, Bulgaria, Canada, Chile, Czechia, France, Hungary, India, Italy, Poland, Romania, Russia, Serbia, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2009
Enrollment StartDec 1, 2009
Primary CompletionJul 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.6 years ago

Interventions

tivozanib (AV-951)drug

Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

Sorafenibdrug

Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.