NCT01458249

An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma (Study E7389-J081-217)

An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	eribulin mesylate	Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-11-01
• Completion: 2016-02-01
• First posted: 2011-10-24
• Last updated: 2016-03-28
• Results posted: 2016-03-28

Locations

12 sites across 1 country: Japan