A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
NCT ID: NCT01673386
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
58 participants
INTERVENTIONAL
2012-07-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Tivozanib Hydrochloride
1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks.
Tivozanib
Sunitinib
50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.
Sunitinib
Interventions
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Tivozanib
Sunitinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed RCC of any histology
* Subjects with or without prior nephrectomy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Central nervous system malignancies or metastases
* Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
* Significant serum chemistry or urinalysis abnormalities
* Significant cardiovascular disease, including symptomatic left ventricular ejection fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled hypertension, myocardial infarction or severe angina within 6 months prior to administration of first dose of study drug, history of class III or IV congestive heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or coronary or peripheral bypass graft within 6 months of screening
* Corrected QT interval (QTc) of \>480 msec using Bazett's formula
* Currently active second primary malignancy
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
AVEO Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Needle, MD
Role: STUDY_CHAIR
AVEO Pharmaceuticals, Inc.
Locations
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Los Angeles, California, United States
Albany, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Shreveport, Louisiana, United States
Worcester, Massachusetts, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
San Antonio, Texas, United States
Madison, Wisconsin, United States
Antwerp, , Belgium
Brussels, , Belgium
Bordeaux, , France
Caen, , France
Lyon, , France
Paris, , France
Berlin, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Munich, , Germany
Aviano, , Italy
Pavia, , Italy
Rome, , Italy
Barcelona, , Spain
Madrid, , Spain
Pamplona, , Spain
Valencia, , Spain
Glasgow, Scotland, United Kingdom
Swansea, Wales, United Kingdom
Cambridge, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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Related Links
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Aveo Pharmaceuticals, Inc. official web page
Other Identifiers
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AV-951-12-205
Identifier Type: -
Identifier Source: org_study_id