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

Status:	Archived
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	October 2010
End Date:	May 2011

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

The purpose of this study is to obtain QTc data, to assess the effects of tivozanib on ECG
morphology, and to determine the pharmacokinetic pharmacodynamic (PK-PD) relationship
between any observed changes in cardiac repolarization (defined by QTcF duration) and the
serum concentration of tivozanib.

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.

We found this trial at

sites

Associates in Oncology and Hematology

Rockville, Maryland 20850

from

Rockville, MD