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Trial record 1 of 1 for:    NCT01343277
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A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

This study is ongoing, but not recruiting participants.
Pharma Mar, S.A.U.
Information provided by (Responsible Party):
Janssen Research & Development, LLC Identifier:
First received: April 26, 2011
Last updated: November 17, 2014
Last verified: November 2014

The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).

Condition Intervention Phase
Advanced Liposarcoma or Leiomyosarcoma
Drug: Trabectedin
Drug: Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • The number of patients with adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 582
Study Start Date: June 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trabectedin Drug: Trabectedin
Type=exactly number, unit=mg/m2, number=1.5, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.
Active Comparator: Dacarbazine Drug: Dacarbazine
Type=exactly number, unit=g/m2, number=1, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.

Detailed Description:

This is a randomized study (study drug assigned by chance) using a 2:1 randomization. It is an open-label (all patients and study staff know the identity of the assigned study drug), active-controlled (comparing to a different drug used for the same condition), parallel-group (different treatment groups continue with separate treatments throughout the study), multicenter study. This study will be divided into three phases, screening, treatment, and follow-up. During screening, potential patients will be assessed for study eligibility after providing signed informed consent. Approximately 570 patients who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n=380) or dacarbazine (n=190) treatment groups. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression (defined by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1 criteria) or signs of toxicity. Assessments will be performed to evaluate the effectiveness of the drug, and patient safety will be monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 mg/m2 through a catheter into a large vein as a 24-hour intravenous (IV) infusion, once every 3 weeks, until disease progression or signs of toxicity. Dacarbazine will be administered at a dose of 1.0 g/m2 as a 20-120 minute infusion, once every 3 weeks, until disease progression or signs of toxicity.


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

Inclusion Criteria:

  • Locally advanced or spreading liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma.
  • Treated in any order with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen.
  • Measurable disease at baseline in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
  • Pathology specimens (eg, tumor blocks or unstained slides) for potential centralized pathology review and biomarker studies.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

  • Prior exposure to trabectedin or dacarbazine.
  • Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent.
  • Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix).
  • Known central nervous system metastasis.
  • Significant chronic liver disease, such as cirrhosis or active viral hepatitis.
  • Heart attack within 6 months before enrollment.
  • Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
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Please refer to this study by its identifier: NCT01343277

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Sponsors and Collaborators
Janssen Research & Development, LLC
Pharma Mar, S.A.U.
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC Identifier: NCT01343277     History of Changes
Other Study ID Numbers: CR018004, ET743SAR3007
Study First Received: April 26, 2011
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health Research Council
South Africa: Medicines Control Council
Brazil: Ministry of Health

Keywords provided by Janssen Research & Development, LLC:
Advanced Liposarcoma or Leiomyosarcoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014