....Zeltia plans to submit Yondelis for the treatment of ovarian cancer to the European Medicines Agency between mid-November and mid-December.
If Yondelis is approved for ovarian cancer treatment, the drug will have a sales potential of 1 billion euros a year, a target which the company hopes to reach by 2012. (Reporting by Tracy Rucinski; Editing by Chris Wickham) ....
PharmaMar ha Actualizado en EE. UU. el Estado de su Ensayo Clínico de FASE III SaLuDo Para el Tratamiento del Leiomiosarcoma Metastásico . La Compañía Confirma Que el Estudio Sigue en FASE de Reclutamiento y Mantiene Como Fecha Estimada de Finalización el 30 de Agosto de 2029 . Según su Presentación Corporativa de Abril de 2026, el Ensayo se Encuentra Aproximadamente en la Mitad de su Desarrollo, lo Que Sugiere una Ejecución en Línea con los Plazos Previstos .
07 noviembre 2008
Yondelis , J&J inicia ensayo clinico a nivel Mundial para evaluar si hay alteraciones en el corazon a traves de ECG en pacientes tratados .
Esperemos que desde Zeltia nos expliquen el potencial de dicho ensayo recien iniciado por J&J .....
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Single Group Assignment, Safety Study
Official Title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
The purpose of the study is to determine the effects of trabectedin on the heart's electrical cycle as measured by electrocardiograms (ECGs) in patients with advanced cancer.
Secondary Outcome Measures:
Assess the safety and pharmacokinetics of trabectedin.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Single Group Assignment, Safety Study
Official Title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
The purpose of the study is to determine the effects of trabectedin on the heart's electrical cycle as measured by electrocardiograms (ECGs) in patients with advanced cancer.
Secondary Outcome Measures:
Assess the safety and pharmacokinetics of trabectedin.
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