CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
E7389 +2 moredrug
Likely dose
E7389 1.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00706095
NCT00706095Phase 1Completed
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An Open-label, Parallel Group Study to Explore the Pharmacokinetics of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors and Normal or Reduced Hepatic Function According to the Child-Pugh System

Eisai Inc.·interventional·Posted Jun 27, 2008·Updated Mar 27, 2012

In Brief

A Phase 1 clinical trial evaluating E7389 for Cancer. Completed, enrolled 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2008
Enrollment StartFeb 1, 2008
Primary CompletionSep 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.0 years ago

Interventions

E7389drug

E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m\^2 for normal hepatic function.

E7389drug

E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m\^2 for mild hepatic impairment (Child-Pugh A)

E7389drug

E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m\^2 for moderate hepatic impairment (Child-Pugh B)