drugset / Trial / NCT01692678
A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to find the optimal dose of trabectedin for Chinese patients with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group is superior to dacarbazine group (Part 2).
Timeline
- Start
- 2012-08-07
- Primary completion
- 2016-10-11
- Completion
- 2016-10-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dacarbazine | Small molecule | 1 g | Intravenous |
| Subject | Trabectedin | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.2 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.5 mg/m2 | Intravenous |