Extract

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).

Inclusion criteria

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

Links

• euctr
• ictrp
• ictrp
• euctr