A Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced RCC
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.
|Carcinoma, Renal Cell||Drug: tivozanib hydrochloride Drug: Sorafenib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma|
- Progression-free survival (PFS) [ Time Frame: 24 months ]
- Overall survival (OS) [ Time Frame: 24 months ]
- Objective response rate (ORR) [ Time Frame: 24 months ]
- Duration of response (DOR) [ Time Frame: 24 months ]
|Study Start Date:||April 2016|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Experimental: Tivozanib hydrochloride
Patients randomized to this arm will receive the study drug, tivozanib hydrochloride.
Drug: tivozanib hydrochloride
Active Comparator: Sorafenib
Patients randomized to this arm will receive the comparator drug, sorafenib.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02627963
|Contact: Darlene Wilsonfirstname.lastname@example.org|
|Contact: Michael Needle, MDemail@example.com|
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|Study Director:||Clinical Trial||AVEO Pharmaceuticals, Inc.|