02 marzo 2013

Yondelis . La Fase III STS , Que Inició en 2011 Janssen tras alcanzar un Nuevo Acuerdo con Zeltia y que Lleva a Cabo en 108 Hospitales Repartidos Entre : EEUU / Brasil / Australia / Nueva Zelanda / Sud-Africa , Podría Tener Primeros Resultados a 12 Meses Vista .

Esta Claro que J&J en esta ocasión y con el nuevo Contrato alcanzado en 2011 Si Apuesta por Yondelis en Sarcoma para EEUU y resto de Paises en los que aún no esta Aprobado .

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Brief title A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma .


Official title A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma .

Recruitment Information


Status Recruiting

Start date 2011-06

Last follow-up date 2014-07 (Anticipated)

Primary completion date 2014-04 (Anticipated)

Administrative Data


Organization name Janssen Research & Development, LLC

Organization study ID CR018004

Secondary ID ET743SAR3007 (Janssen Research & Development, LLC)

Sponsor Janssen Research & Development, LLC

Collaborator Pharma Mar, S.A.U.

Health Authority United States: Food and Drug Administration

Health Authority Australia: Department of Health and Ageing Therapeutic Goods Administration

Health Authority New Zealand: Health Research Council

Health Authority South Africa: Medicines Control Council

Health Authority Brazil: Ministry of Health