A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma

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