drugset / Trial / NCT00706095

Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System

NCT00706095

Phase 1 Completed 18 enrolled Eisai Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for classifying hepatic impairment.

Timeline

Start
2008-02
Primary completion
2009-09
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 0.7 mg/m2 Intravenous
Subject Eribulin Small molecule 1.1 mg/m2 Intravenous
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous

Indications