drugset / Trial / NCT01692678

A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma

NCT01692678

Phase 3 Completed 16 enrolled Xian-Janssen Pharmaceutical Ltd.
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

EvaluationDrugModalityDoseRoute
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

Indications