NCT01210846

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	tivozanib	1 x 1.5 mg capsule of tivozanib orally once daily for 21 days

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2010-09-29
• Last updated: 2011-09-26

Locations

8 sites across 1 country: United States