A Cardiac Safety Study of Tivozanib to Evaluate the Electrocardiogram and Pharmacokinetic-Electrocardiogram Dynamics in Subjects With Advanced Solid Tumors

Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor
(VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2,
and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong
antiangiogenesis and antitumor activity.

This study is an open-label, non-randomized, exploratory single-arm trial evaluating the ECG
and pharmacokinetic (PK)-ECG relationship, if any, of tivozanib in subjects with advanced
solid tumors.

The purpose of this study is to evaluate the ECG intervals and morphology following
treatment with tivozanib in subjects with advanced solid tumors and to determine the
relationship, if any, of the change in QTc duration with serum concentration of tivozanib
over time in subjects with advanced solid tumors.