A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

Stopped early · Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT01673386

Run by

AVEO Pharmaceuticals, Inc.

People needed

58

Starts

2012-07-01

Expected to finish

2014-01-01

Last updated by the study team

2020-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Albany, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — New York, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Charleston, South Carolina, United States
• Study site — Myrtle Beach, South Carolina, United States
• Study site — San Antonio, Texas, United States
• Study site — Madison, Wisconsin, United States
• Study site — Antwerp, Belgium
• Study site — Brussels, Belgium
• Study site — Bordeaux, France
• Study site — Caen, France
• Study site — Lyon, France
• Study site — Paris, France
• Study site — Berlin, Germany
• Study site — Hamburg, Germany
• Study site — Hanover, Germany
• Study site — Heidelberg, Germany

Full record on ClinicalTrials.gov

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