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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

Phase 3
15 Years
Open (Enrolling)

Thank you

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.

Inclusion Criteria:

- All soft tissue sarcoma types excluding liposarcoma and leiomyosarcoma (L-type soft
tissue sarcoma) that cannot be surgically removed and is in an advanced stage or has

- Must have relapsed or had progressive disease following standard of care treatment
prior to enrollment or intolerant to standard of care treatment 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)

- Male and female patients surgically sterile, abstinent, or practicing an effective
method of birth control and female patients have a negative urine or serum pregnancy
test result at screening

Exclusion Criteria:

- 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 patient who is pregnant or breastfeeding

Type of Study:


Study Design:

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

Outcome Measure:

Number of patients experiencing adverse events

Outcome Time Frame:

30 days after last dose of study medication

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

December 2015

Related Keywords:

  • Sarcoma
  • Sarcoma
  • non L-type Soft tissue sarcoma
  • Standard care
  • Trabectedin
  • Antitumor agent
  • Safety
  • Sarcoma



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