NCT01106248

QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

An Open-Label, Multicenter, Single Arm QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.

Detailed description

This is an open-label, multicenter, single arm QT Interval prolongation study of eribulin mesylate (E7389) in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	1.4 mg/m\^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-09-01
• First posted: 2010-04-19
• Last updated: 2012-04-13
• Results posted: 2012-04-13

Locations

2 sites across 1 country: France