View of NCT01692678 on 2013-10-23 .Ensayo de Fase III que se inició en China de la mano de Xian - Janssen hace poco más de un año .
Descriptive Information :
Brief title : A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma .
Brief 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).
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Recruitment Information :
Status : Recruiting
Start date : 2012-08
Last follow-up date : 2018-03 (Anticipated)
Primary completion date : 2014-10 (Anticipated)
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Administrative Data :
Organization name : Xian-Janssen Pharmaceutical Ltd.
Organization study ID : CR017269
Secondary ID : ET743SAR3006 (Xian-Janssen Pharmaceutical Ltd., China)
Sponsor : Xian-Janssen Pharmaceutical Ltd.
Health Authority China : Food and Drug Administration
Health Authority China : Ethics Committee