drugset / Trial / NCT00060944
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Phase 2
Completed
271 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
Timeline
- Start
- 2003-05
- Primary completion
- 2008-05
- Completion
- 2008-05
Outcome
Met primary endpoint
registry Trabectedin 1.5 mg/m2 vs Trabectedin 0.58 mg/m2; p = 0.0302; Hazard Ratio (HR) 0.734 (95% CI 0.554 to 0.974); Log Rank NCT00060944 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trabectedin | Small molecule | 0.58 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.5 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Intravenous |