A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).
Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.
Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).
All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.
Pharmacokinetic (PK) analyses are also included in study.
Inclusion Criteria:
Exclusion Criteria:
Hackensack, New Jersey 07601, United States
Winston-Salem, North Carolina 27157, United States
Saint-Priest-en-Jarez, Pays de la Loire Region 42271, France
Miskolc, Borsod-Abauj Zemplen county 3526, Hungary
Otwock, Masovian Voivodeship 05-400, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Badalona, Barcelona 08916, Spain