Eribulin compared to Dacarbazine in patients with soft tissue sarcoma
Research type
Research Study
Full title
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin with Dacarbazine in Subjects with Soft Tissue Sarcoma
IRAS ID
75953
Contact name
Michael Leahy
Sponsor organisation
Eisai Limited
Eudract number
2010-024483-17
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to compare eribulin (an experimental treatment for sarcoma) with a standard treatment for sarcoma called dacarbazine. The safety (side effects) and efficacy (how sarcoma responds to treatment) will be compared for the 2 treatments. Soft tissue sarcomas are cancers of the supporting tissues of the body, including the muscles, nerves, fat, blood vessels and deep skin tissues. This study is looking at 2 sub-types of sarcoma:-liposarcoma and leiomyosarcoma.Eligible patients will be randomly assigned to receive either eribulin or dacarbazine. Randomisation is assignment to one treatment or the other by chance (like flipping a coin).Study treatment will be given in 3 weekly cycles until disease progression, unacceptable toxicity, or withdrawal of consent.Procedures to be performed at the study visits include measurement of vital signs (blood pressure, heart rate and body temperature), physical examination, ECG (heart tracing), routine blood and urine tests, and completion of quality of life questionnaires. Assessment of disease by CT/MRI scan will also be performed regularly.This study is sponsored by Eisai Limited. Approximately 450 patients will participate in this study in about 20 countries worldwide.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/NW/0334
Date of REC Opinion
12 Jul 2011
REC opinion
Further Information Favourable Opinion