A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available 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). 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.

Inclusion Criteria:

- Unresectable advanced or metastatic histologically proven soft tissue sarcoma (STS).
Eligibility will include adult participants with desmoplastic small round cell tumor

- Must have relapsed or had progressive disease following standard of care treatment
with chemotherapy prior to enrollment or intolerant to prior standard of care
treatment with chemotherapy due to safety issues

- Recovery from toxic effects of prior therapies to Grade 1 or better according to
National Cancer Institute-Common Terminology Criteria of Adverse Events (criteria used
to grade the severity of toxic effects on a scale from 0 to 5 - Grade 1 = mild in
severity, Grade 0 = no severity)

- Clinical test results within acceptable limits (ie, hematologic, clinical chemistry
and hepatic function test results)

- Female participants must be postmenopausal, surgically sterile, abstinent, or if
sexually active, be practicing 2 effective methods of birth control (eg, prescription
hormonal contraceptive, intrauterine device, double-barrier method [eg, condoms,
occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, cream, gel,
film, or suppository]), before entry, and must agree to continue to use these same
methods of contraception throughout the study and for 3 months thereafter. Male
participants must agree to use an adequate contraception method as deemed appropriate
by the investigator (eg, vasectomy, double-barrier, partner using effective
contraception) and to not donate sperm for a minimum of 5 months after treatment
discontinuation

Exclusion Criteria:

- Diagnosis of Ewing's sarcoma or osteosarcoma, less than 3 weeks from last dose of
radiation, systemic cytotoxic therapy (or 4 half lives, whichever is longer)

- Active symptomatic viral hepatitis or chronic liver disease

- Significant uncontrolled cardiac condition, including New York Heart Association Class
II or greater heart failure, uncontrolled angina pectoris, myocardial infarction
within 6 months before enrollment, significant pericardial disease, or uncontrolled or
arrhythmias

- Active infection

- Female participant who is pregnant or breastfeeding