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

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AVEO Pharmaceuticals, Inc.
• Collaborator: Astellas Pharma Inc
• Treatments: Sunitinib

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