Eisai Clinical Trials

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

E7389-G000-309

Study Overview

E7389
eribulin mesilate
NCT01327885, 2010-024483-17
Mar 2011 - Aug 2016
Soft Tissue Sarcoma

1. Overall Survival (OS) [Time Frame: From date of treatment start until date of death from any cause, up to 5 years 5 months]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Completed

  • Phase 3

  • Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Romania, Russian Federation, Singapore, Spain, Thailand, United Kingdom, United States See more

Results

CSR Synopsis

Download PDF

Lay Summary

Download PDF
Publication reference citation

Schoffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D’Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR