Estudio Fase I/II de PHA-848125AC administrado diariamente por vía oral durante 14 días consecutivos cada tres semanas en pacientes con glioma maligno recurrente

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003193-10

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

Phase I part: - To determine the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of PHA-848125AC administered orally once daily for 14 consecutive days followed by 7 days of rest (3-week cycle) in adult patients with recurrent malignant glioma - To establish the dose recommended for the phase II (RP2D) part of the trial. Phase II part: - To evaluate antitumor activity of PHA-848125AC in recurrent glioblastoma multiforme (GBM) patients, assessed as percentage of patients alive and progression-free at 6 months (PFS-6 rate).


Critère d'inclusion

  • Phase I Part: Glioma Maligno recurrente Phase II Part: Glioblastoma (GBM) recurrente