Thursday, November 3, 2011

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

Johnson & Johnson announces a clinical trial.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and PharmaMar are conducting a Phase 3 clinical trial for trabectedin or dacarbazine in patients with liposarcoma or leiomyosarcoma. This is a randomized (study drug assigned by chance), 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. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression 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-minute infusion, once every 3 weeks, until disease progression or signs of toxicity. For more information on this study, please visit www.l-sarcomastudy.com or www.clinicaltrials.gov (Identifier # NCT01343277).

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