A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC (TAURUS)
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ClinicalTrials.gov Identifier: NCT01673386 |
Recruitment Status :
Terminated
(Sponsor)
First Posted : August 28, 2012
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
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Sponsor:
AVEO Pharmaceuticals, Inc.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | August 23, 2012 | |||
First Posted Date ICMJE | August 28, 2012 | |||
Results First Submitted Date ICMJE | July 7, 2020 | |||
Results First Posted Date ICMJE | October 27, 2020 | |||
Last Update Posted Date | October 27, 2020 | |||
Study Start Date ICMJE | July 2012 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib [ Time Frame: Up to 25 weeks ] The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
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Original Primary Outcome Measures ICMJE |
Proportion of subjects who prefer tivozanib hydrochloride or sunitinib [ Time Frame: Up to 25 weeks ] | |||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC | |||
Official Title ICMJE | A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma | |||
Brief Summary | Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC). | |||
Detailed Description | This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2 treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and sunitinib sequentially. The study is designed to compare subject treatment preference, as well as overall safety and tolerability, frequency of dose modifications and kidney-specific health outcomes/QoL. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Renal Cell Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | Terminated | |||
Actual Enrollment ICMJE |
58 | |||
Original Estimated Enrollment ICMJE |
160 | |||
Actual Study Completion Date ICMJE | January 2014 | |||
Actual Primary Completion Date | January 2014 (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, France, Germany, Italy, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01673386 | |||
Other Study ID Numbers ICMJE | AV-951-12-205 | |||
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 | Astellas Pharma Inc | |||
Investigators ICMJE |
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PRS Account | AVEO Pharmaceuticals, Inc. | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |