30 septiembre 2009

J&J actualiza la Fase III que Evalua la Efectividad del Yondelis frente a la terapia Standar para 1ª Linea en Pacientes con Avanzado TRS .

Ensayo Clinico que J&J inicio en Noviembre del 2008 .

View of NCT00796120 on 2009_09_28
ClinicalTrials Identifier: NCT00796120
Updated: 2009_09_28


*.- A randomized, multicenter, Phase III trial to evaluate the effectiveness of trabectedin versus standard doxorubicin-based chemotherapy (DXCT) as first-line treatment of patients with advanced TRS, by comparing progression-free survival (PFS) in the two treatment arms.

*.- Detailed description
Treatment Arm A: Trabectedin. Treatment Arm B: Doxorubicin as a single agent or in combination with ifosfamide Trabectedin 1.5 mg/m2 given intravenously over 24-hours; or doxorubicin 75 mg/m2 intravenously every 3 weeks, or doxorubicin 60 mg/m2 intravenously followed by ifosfamide in the range of 6 to 9 g/m2 every 3 weeks with proper hydration and ifosfamide chemoprotectant drugs.

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