drugset / Trial / NCT01945710

An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients With Solid Tumors

NCT01945710

Phase 1 Completed 62 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Study E7389-E044-112 is a Phase 1 study designed to assess the safety, tolerability and preliminary efficacy of eribulin-liposomal formulation (E7389-LF) in patients with solid tumors. This dose-escalation study will determine the maximum tolerated dose, dosing schedules tested, the dose schedule regimen with a more favorable tolerability profile, and a preliminary indication of efficacy.

Timeline

Start
2012-12-11
Primary completion
2015-10
Completion
2016-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 1 mg/m2 Intravenous
Subject Eribulin Small molecule 3.5 mg/m2 Intravenous

Indications