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A Study to Provide Access to Trabectedin in Patients With Non L-type Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC Identifier:
First received: September 13, 2005
Last updated: November 19, 2014
Last verified: November 2014

The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.

Condition Intervention Phase
Drug: Trabectedin
Phase 3

Janssen Research & Development, LLC has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Number of patients experiencing adverse events [ Time Frame: 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: August 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trabectedin
trabectedin1.5mg/m2 as 24hr infusion on day 1 of each 21 day cycle
Drug: Trabectedin
Type= exact number, unit= mg/m2, number= 1.5, form= intravenous infusion, route= intravenous use. 1.5mg/m2 as 24hr infusion on day 1 of each 21 day cycle

Detailed Description:

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.


Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 spread
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00210665

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

  Show 37 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided by Janssen Research & Development, LLC

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC Identifier: NCT00210665     History of Changes
Obsolete Identifiers: NCT00707109
Other Study ID Numbers: CR003583, ET743SAR3002
Study First Received: September 13, 2005
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
non L-type Soft tissue sarcoma
Standard care
Antitumor agent

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2014