Kidney Cancer Clinical Trial
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
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).
Full 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.
Eligibility Criteria
Inclusion Criteria:
Unresectable mRCC
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:
Any prior systemic therapy for treatment of mRCC (including investigational or licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of rapamycin [mTOR] inhibitors)
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
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There are 15 Locations for this study
Los Angeles California, 90001, United States
Albany Georgia, 31701, United States
Atlanta Georgia, 30301, United States
Chicago Illinois, 60007, United States
Indianapolis Indiana, 46077, United States
Shreveport Louisiana, 71101, United States
Worcester Massachusetts, 01601, United States
Minneapolis Minnesota, 55111, United States
New York New York, 10001, United States
Columbus Ohio, 43004, United States
Portland Oregon, 97035, United States
Charleston South Carolina, 29401, United States
Myrtle Beach South Carolina, 29572, United States
San Antonio Texas, 78006, United States
Madison Wisconsin, 53558, United States
Antwerp , , Belgium
Brussels , , Belgium
Bordeaux , , France
Caen , , France
Lyon , , France
Paris , , France
Berlin , , Germany
Hamburg , , Germany
Hannover , , 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
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