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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

Phase 3
18 Years
Open (Enrolling)

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Trial Information

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.

Inclusion Criteria:

- Male or female subject aged ≥18 years.

- Unresectable advanced or metastatic histologically proven STS. Eligibility will
include desmoplastic small round cell tumor, Ewing's sarcoma, and osteosarcoma.

- Subjects 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 (NCI-CTCAE,
Version 3).

- Hematologic test results:

- Hemoglobin ≥8 g/dL

- Absolute neutrophil count (ANC) ≥1,500/μL

- Platelet count ≥100,000/μL

- Clinical chemistry test results:

- If serum creatinine ≤1.5 times the upper limit of normal (ULN), or if serum
creatinine is >1.5 times the ULN, then 24 hour creatinine clearance of >50 cc/min,
creatine phosphokinase (CPK) ≤2.5 times the ULN

- Hepatic function test results:

- Total bilirubin ≤ULN, if increased then measure indirectly to rule out Gilbert's
syndrome. If direct bilirubin is within normal limits, subject may be considered

- Total alkaline phosphatase ≤1.5 times the ULN, or if liver metastases are present,
then alkaline phosphatase may be ≤2.5 times the ULN.

- AST and ALT must be ≤2.5 times the ULN.

- Female subjects must be surgically sterile, abstinent, or, if sexually active, be
practicing an effective method of birth control (e.g., prescription oral
contraceptives, contraceptive injections, intrauterine device, double-barrier method,
contraceptive patch) before entry and throughout the study, and have a negative urine
or serum pregnancy test result at screening. For male subjects and partners,
acceptable methods of birth control include sterilization, barrier contraception, and

- Subjects must have signed an informed consent document indicating that they
understand the purpose of and procedures required for the study and are willing to
participate in the study.

Exclusion Criteria:

- Less than 3 weeks from the last dose of radiation therapy; last dose or 4 half lives
of systemic cytotoxic therapy; therapy with any investigational agent; less than 2
weeks from the last dose of radiation therapy with any investigational agent or
systemic therapy, provided all side effects from those therapies have resolved to
Grade 1 or less.

- Active viral hepatitis or chronic liver disease.

- Unstable cardiac condition, including congestive heart failure or angina pectoris,
myocardial infarction within 1 year before enrollment, uncontrolled arterial
hypertension or arrhythmias.

- Active infection.

- Female subject who is pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

30 days after the last dose of the investigational product

Safety Issue:


Principal Investigator

Senior Director of Clinical Research

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Sarcoma
  • Sarcoma



University of Medicine and Dentistry of New Jersey Newark, New Jersey  07103-2425