NCT01327885

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Eribulin mesylate 1.4 mg/m^2 intravenous	Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an intravenous (IV) bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.
DRUG	Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV	Administration of dacarbazine at a dose of 850 mg/m\^2, or 1,000 mg/m\^2, or 1,200 mg/m\^2 selected by the Principal Investigator \[PI\] or designee according to the subject's clinical status as an IV infusion over 15-30 minutes on Day 1 of every cycle, where the duration of each cycle is 21 days.

Timeline

• Start date: 2011-03-10
• Primary completion: 2015-01-02
• Completion: 2016-08-10
• First posted: 2011-04-04
• Last updated: 2023-06-22
• Results posted: 2017-02-28

Locations

119 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Thailand, United Kingdom