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A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

Phase 3
15 Years
Open (Enrolling)
Advanced Liposarcoma or Leiomyosarcoma

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Trial Information

A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced 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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Approximately 3 years

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

July 2014

Related Keywords:

  • Advanced Liposarcoma or Leiomyosarcoma
  • Advanced Liposarcoma or Leiomyosarcoma
  • Trabectedin
  • Yondelis
  • Dacarbazine
  • Anthracycline
  • L-sarcoma
  • Leiomyosarcoma
  • Liposarcoma



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