Advanced Renal Cell Carcinoma Clinical Trial
Official title:
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)
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.
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.
Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib and stratified by
geographic region (North America/Western Europe, Central/Eastern Europe, or rest of the
world); number of prior treatments (0 or 1); and number of metastatic sites/organs involved
(1 or ≥ 2).
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|---|---|---|---|
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