Eisai Clinical Trials

A Phase 1/2 single-arm study evaluating the safety and efficacy of eribulin mesilate in combination with irinotecan in children with refractory or recurrent solid tumors

E7389-G000-213

Study Overview

E7389
eribulin mesilate
NCT03245450, 2016-003352-67, SNCTP000004098
Mar 2018 - May 2021
Refractory or Recurrent Solid Tumors
1. Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride [Time Frame: First dose of study drug up to Cycle 1 (Cycle length=21 days)]

2. Phase 2: Objective Response Rate (ORR) [Time Frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or up to approximately 2 years 4 months]

  • Males and females 6 Months to 25 Years (Child, Adult)

  • Completed

  • Phase 1 / 2

  • France, Germany, Greece, Italy, Poland, Spain, Switzerland, United Kingdom See more

Results

CSR Synopsis

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Data Sharing

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CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

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Protocol
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Full CSR