A study to compare how safe Aldoxorubicin is and how well it works against known treatments in patients with soft tissue sarcoma Estudio para comparar cómo es de segura la aldoxorrubicina y si f...

Update Il y a 4 ans
Reference: EUCTR2013-004103-40

A study to compare how safe Aldoxorubicin is and how well it works against known treatments in patients with soft tissue sarcoma Estudio para comparar cómo es de segura la aldoxorrubicina y si funciona bien respecto a otros tratamientos conocidos en pacientes con sarcoma de tejido blando

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Extract

The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator's choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed or were refractory to prior non-adjuvant chemotherapy, as measured by progression-free survival (PFS). El objetivo principal de este estudio es determinar la eficacia de la administración de aldoxorrubicina en comparación con la elección terapéutica del investigador, en pacientes con sarcomas de tejido blando no resecables, localmente avanzados o metastásicos, recidivantes o resistentes a la quimioterapia previa no adyuvante, determinado mediante la supervivencia sin progresión (SSP).


Inclusion criteria

  • Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma,Sarcoma de tejido blando metastásico, localmente avanzado o no resecable