drugset / Trial / NCT01210846

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

NCT01210846

Phase 1 Completed 50 enrolled AVEO Pharmaceuticals, Inc.
NaSingle-groupOpen-label

Summary

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.

Timeline

Start
2010-10
Primary completion
2011-03
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tivozanib Small molecule 1.5 mg Oral

Indications