A Multicenter, Open-Label Single-Arm Study of Trabectedin for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment
This study is designed to accommodate individual requests for treatment with trabectedin
before the drug becomes commercially available. In regions where trabectedin becomes
commercially available and reimbursable in that particular country, an administrative cutoff
for further accrual will be set.
Subjects with STS who have relapsed following standard of care treatment or who are
refractory to or intolerant of standard therapies but who may benefit from treatment may
participate in this study. The safety profile of the drug will be further evaluated.
Eligible subjects will receive a dose of 1.5 mg/m2 trabectedin intravenous (i.v.)
formulation administered as a 24-hour infusion on Day 1 of each 17- to 49-day treatment
Tumor assessment will be performed prior to administration of the first dose (Cycle 1, Day
1) and thereafter approximately every 2 cycles according to institutional standards.
The number of cycles is not specified for this study. Subjects may continue to receive
treatment as long as they derive an overall clinical benefit, i.e., until there is clear
evidence of disease progression or unacceptable toxicity, as judged by the investigator.
Safety evaluation will include physical examinations, monitoring vital signs and adverse
events, and collecting hematology and clinical chemistry test results. Minimal efficacy data
will be collected and includes tumor assessments and survival information.
An administrative cutoff for further study accrual will be set in regions where trabectedin
commercially becomes available and reimbursable in that particular country if applicable.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events will be evaluated for the length,severity of each episode, action taken with respect to the investigational product, investigator's evaluation of its relationship to the investigational product, and the outcome.
30 days after the last dose of the investigational product
Senior Director of Clinical Research
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration
|University of Medicine and Dentistry of New Jersey||Newark, New Jersey 07103-2425|