A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (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 : July 18, 2023
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Tracking Information | |||
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First Submitted Date ICMJE | December 9, 2015 | ||
First Posted Date ICMJE | December 11, 2015 | ||
Results First Submitted Date ICMJE | January 16, 2020 | ||
Results First Posted Date ICMJE | February 20, 2020 | ||
Last Update Posted Date | July 18, 2023 | ||
Actual Study Start Date ICMJE | May 24, 2016 | ||
Actual Primary Completion Date | October 4, 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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 (up to approximately 5 years) ] The 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.
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Original Primary Outcome Measures ICMJE |
Progression-free survival (PFS) [ Time Frame: 24 months ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) | ||
Official Title ICMJE | A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma | ||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Renal Cell | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
350 | ||
Original Estimated Enrollment ICMJE |
322 | ||
Actual Study Completion Date ICMJE | June 21, 2021 | ||
Actual Primary Completion Date | October 4, 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States | ||
Removed Location Countries | Czech Republic | ||
Administrative Information | |||
NCT Number ICMJE | NCT02627963 | ||
Other Study ID Numbers ICMJE | AV-951-15-303 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | AVEO Pharmaceuticals, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | AVEO Pharmaceuticals, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | AVEO Pharmaceuticals, Inc. | ||
Verification Date | June 2023 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |