A Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced RCC
Status:
Completed
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center,
parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced
renal cell carcinoma (RCC).
Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.
Subjects 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 subjects 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) analysis are also included in study.