drugset / Trial / NCT00796120

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

NCT00796120

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2008-11
Primary completion
2012-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Comparator Ifosfamide Small molecule 6 g Intravenous
Comparator Ifosfamide Small molecule 9 g Intravenous
Subject Trabectedin Small molecule 1.5 mg/m2 Intravenous

Indications