drugset / Trial / NCT01104298

Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

NCT01104298

Phase 2 Terminated 115 enrolled Spanish Group for Research in Sarcomas
RandomizedParallel-groupOpen-labelTreatment

Summary

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy

Timeline

Start
2009-11
Primary completion
2012-12
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Subject Trabectedin Small molecule 1.1 mg/m2 Intravenous

Indications