Trial Information

A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

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.