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An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

NCT00796120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-12-10

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

Conditions

  • Sarcoma

Interventions

DRUG

Trabectedin

Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.

DRUG

Doxorubicin

Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression.

DRUG

Ifosfamide

Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-08-31
Completion
2014-08-31

Countries

  • United States
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796120 on ClinicalTrials.gov