A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

• Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  

• Progression-free survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  
• Time to progression [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  
• Objective response rate [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  
• Duration of response [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  
• The number of patients with adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  

This is a randomized study (study drug assigned by chance) using a 2:1 randomization. It is an open-label (all patients and study staff know the identity of the assigned study drug), active-controlled (comparing to a different drug used for the same condition), parallel-group (different treatment groups continue with separate treatments throughout the study), multicenter study. This study will be divided into three phases, screening, treatment, and follow-up. During screening, potential patients will be assessed for study eligibility after providing signed informed consent. Approximately 570 patients who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n=380) or dacarbazine (n=190) treatment groups. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression (defined by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1 criteria) or signs of toxicity. Assessments will be performed to evaluate the effectiveness of the drug, and patient safety will be monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 mg/m2 through a catheter into a large vein as a 24-hour intravenous (IV) infusion, once every 3 weeks, until disease progression or signs of toxicity. Dacarbazine will be administered at a dose of 1.0 g/m2 as a 20-120 minute infusion, once every 3 weeks, until disease progression or signs of toxicity.