A Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced RCC
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|ClinicalTrials.gov Identifier: NCT02627963|
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : February 20, 2020
Last Update Posted : January 26, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: tivozanib hydrochloride Drug: Sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||June 2021|
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.
- Progression-free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks. ]Progression-Free Survival (PFS), as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival (OS) [ Time Frame: Date of randomization to date of death ]Overall survival (OS) is defined as the time from the date of randomization to date of death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: Every 8 weeks from date of randomization until disease progression ]Objective response rate (ORR) is defined as the percentage of subjects who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).
- Duration of Response (DOR) [ Time Frame: Assessed every 8 weeks from date of randomization until date of progression ]Duration of response (DOR) is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627963