A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)
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|ClinicalTrials.gov Identifier: NCT01030783|
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : March 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Renal Cell Carcinoma||Drug: tivozanib (AV-951) Drug: Sorafenib||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||517 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||June 2013|
|Experimental: tivozanib (AV-951)||
Drug: tivozanib (AV-951)
Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
|Active Comparator: sorafenib||
Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
- To compare the progression-free survival (PFS) of subjects with advanced renal cell cancer (RCC) randomized to treatment with tivozanib or sorafenib [ Time Frame: 24 months ]
- To compare the overall survival (OS) of subjects randomized to treatment with tivozanib or sorafenib [ Time Frame: 24 months ]
- To compare objective response rate (ORR) and duration of response (DR) of subjects randomized to treatment with tivozanib or sorafenib [ Time Frame: 24 months ]
- To compare the safety and tolerability of tivozanib and sorafenib [ Time Frame: 24 months ]
- To compare kidney-specific symptoms and health outcome measurements in subjects randomized to treatment with tivozanib or sorafenib [ Time Frame: 24 months ]
- To evaluate the pharmacokinetics (PK) of tivozanib [ Time Frame: 12 months ]
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): NCT01030783
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|Principal Investigator:||Robert J. Motzer, MD||Memorial Sloan Kettering Cancer Center|