Conditions: Soft Tissue Sarcoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Eribulin mesylate 1.4 mg/m^2 intravenous intervention 2: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: