MedTrace Logo

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

NCT01210846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

tivozanib

1 x 1.5 mg capsule of tivozanib orally once daily for 21 days

Sponsors & Collaborators

  • AVEO Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Vargo, MD · AVEO Pharmaceuticals, Inc.

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-03-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210846 on ClinicalTrials.gov