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

INTERVENTION: Administration of eribulin mesylate at a dose of 1.4 mg/m2 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. Treatment will continue until disease progression, development of unacceptable toxicity or withdrawal of consent. CONDITION: Soft tissue sarcoma PRIMARY OUTCOME: Overall survival measured from the date of randomisation until date of death from any cause. SECONDARY OUTCOME: To compare progression‐free survival (PFS) between Arm A and Arm B. INCLUSION CRITERIA: 1. Histologically confirmed diagnosis of soft tissue sarcoma of high or intermediate grade with one of the following histological subtypes: a. Adipocytic sarcoma b. Leiomyosarcoma. 2. Documented evidence of advanced adipocytic or leiomyosarcoma, incurable by surgery and/or radiotherapy. 3. Subjects should have received at least two standard systemic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline (unless contraindicated). 4. Radiographic evidence of disease progression within the 6 months prior to randomization. 5. Presence of measurable disease. 6. Eastern Cooperative Oncology Group, performance status of 0, 1 or 2. 7. Adequate renal function. 8. Adequate bone marrow function. 9. Adequate liver function.