A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pharma Mar, S.A.U.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01343277
First received: April 26, 2011
Last updated: June 23, 2014
Last verified: June 2014

April 26, 2011
June 23, 2014
June 2011
December 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Evaluation of overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01343277 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Liposarcoma or Leiomyosarcoma
  • 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.
  • 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.
  • Experimental: Trabectedin
    Intervention: Drug: Trabectedin
  • Active Comparator: Dacarbazine
    Intervention: Drug: Dacarbazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
582
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   New Zealand
 
NCT01343277
CR018004, ET743SAR3007
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Pharma Mar, S.A.U.
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP