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

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

Outcome

Met primary endpoint

release “tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1” aveooncology.com ↗

release “The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1” aveooncology.com ↗

release “In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS), the primary endpoint of the study, when compared with sorafenib.” astellas.com ↗

release “In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study” astellas.com ↗

release “In the global Phase III trial (TIVO-1) 1 of over 500 patients with advanced RCC, tivozanib demonstrated a significant PFS benefit versus sorafenib” aveooncology.com ↗

Publications

• Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Sorafenib	Small molecule	400 mg	Oral
Subject	Tivozanib	Small molecule	1.5 mg	Oral

Indications