First received : February 9, 2011 .
Last updated : February 26, 2013 .
Last verified : February 2013 .
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors .
Recruitment Information
Status Recruiting
Start date 2011-01
Last follow-up date 2013-08 (Anticipated)
Primary completion date 2013-08 (Anticipated)
Organization name PharmaMar
Organization study ID PM60184-A-002-10
Sponsor PharmaMar
Health Authority United States: Food and Drug Administration
DESPUES DE 18 AÑOS CON SOLO TOPOTECAN CON FULL APPROVAL EN EEUU COMO TREATMENT 2a LÍNE SCLC-ES ... LA USFDA ACABA DE APROBAR AL TARLATAMAB CON FULL APPROVAL ... POR LO QUE ES YA EL NEW TREATMENT STÁNDARD EN EEUU . TIENE APROBACIÓNES ACELERADAS EN CANADA , UK, COREA ... Y EN DÍAS PODRÍA ALCANZAR LA APROBACIÓN TAMBIÉN EN CHINA QUE EN JULIO 2025, LA NMPA ACEPTÓ LA SOLICITUD DE REGISTRO (NDA) PARA TARLA OTORGÁNDOLE ADEMAS LA REVISIÓN PRIORITARIA . LA EMA TAMBIÉN LO ESTÁ YA EVALUANDO .
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
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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
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