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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: tivozanib

• Registration Number: NCT01210846
• Lead Sponsor: AVEO Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-29
• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tivozanib	tivozanib	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in QTcF	22 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in heart rate (HR)	22 days
Change from baseline in QTc with Bazett correction method (QTcB)	22 days
Change from baseline in PR interval	22 days
Change from baseline in QRS interval	22 days
Change from baseline in Uncorrected QT interval	22 days
Change from baseline in ECG morphological patterns	22 days
Correlation between the QTcF change from baseline and serum concentrations of tivozanib	22 days

Trial Locations

Locations (8)

Associates in Oncology/Hematology; 🇺🇸 Rockville, Maryland, United States

Tennessee Onocology; 🇺🇸 Nashville, Tennessee, United States

Oklahoma University Cancer Institute (OUCI); 🇺🇸 Oklahoma City, Oklahoma, United States

Multicare Research Institute/Tacoma General Hospital; 🇺🇸 Tacoma, Washington, United States

Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC; 🇺🇸 Metairie, Louisiana, United States

Florida Cancer Specialists; 🇺🇸 Ft. Myers, Florida, United States

TGEN Clinical Research Service at Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Horizon Oncology Research, Inc.; 🇺🇸 Lafayette, Indiana, United States