Trial Information

A Multicenter, Open-Label Single-Arm Study of YONDELIS (Trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Excluding Leiomyosarcoma and Liposarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment

This is a multicenter, open-label (all people know the identity of the intervention),
single-arm study. It will consist of 2 Phases: a Screening Phase (up to 21 days before the
first dose administration), and Treatment Phase (for patients meeting the continuation
criteria). During the Treatment Phase, patients will receive a dose of 1.5 mg/m2 trabectedin
intravenous formulation administered as a 24-hour infusion on Day 1 of each suggested 21-day
treatment cycle. All patients will receive 20 mg dexamethasone (or corticosteroid equivalent
to dexamethasone), anti-inflammatory agent, administered by vein 30 minutes before each
trabectedin dose. Number of cycles is not specified for this study. Patients may continue to
receive treatment as long as they obtain an overall clinical benefit, ie, until there is
clear evidence of disease progression or unacceptable toxicity, as judged by the
investigator. Trabectedin is the first of a new class of antitumor agents. Previous studies
with trabectedin in patients who had been previously treated for soft tissue sarcoma have
suggested that treatment with trabectedin resulted in tumor shrinkage, disease
stabilization, and improved survival rates. However, hematologic toxicity, hepatic toxicity,
and renal impairment were also observed in these patients. The safety profile of trabectedin
will be evaluated to further assess the potential risks of trabectedin treatment in patients
previously treated for soft tissue sarcoma who are not expected to benefit from currently
available therapeutic options for treatment of soft tissue sarcoma. Safety will be monitored
throughout the study.