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).

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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.

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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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT01673386

Recruitment Status:

Terminated

Sponsor:

AVEO Pharmaceuticals, Inc.

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There are 15 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT01673386

Recruitment Status:

Terminated

Sponsor:


AVEO Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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