drugset / Trial / NCT00796120
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Phase 3
Completed
121 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |