It is an open multicentric phase I/II trial with axitinib (Inlyta®) and metronomic delivery of etoposide for children, adolescent and young adults (AYA) with refractory/ relapsing solid tumors. It is a two-stage trial:
First stage: To determine the Maximum Tolerated Dose (MTD) of the combination of axitinib and oral metronomic etoposide for patient with medulloblastoma or ependymoma Second stage: Extension cohort evaluating the preliminary efficacy at the recommended dose for the phase II (RDP2) of the combination. The 2nd stage will start after a meeting of independent data monitoring committee (IDMC). Two cohorts of 9 patients with ependymoma and medulloblastoma Patients treated at first stage won't be included in the second stage.
Histologically proven diagnosis of ependymoma or medulloblastoma
Methyloma classification performed or available material for methyloma analysis
Confirmed progressive or refractory disease despite standard therapy, or for which no effective standard therapy exists
Male and female subjects with > 4 to ≤ 25 years of age at inclusion
None
Single group
administration of axitinib in combination with etoposide
Drug1. st stage: * Axitinib (Inlyta®) PO, in the morning and in the evening every day * Level -1 : Dose 1.2 mg/m² * Level 1: Dose 1.6 mg/m² * Level 2: Dose 2.0 mg/m² * Level 3: Dose 2.4 mg /m² (equivalent to 4 mg in adults) * Etoposide (50 mg capsules or in the form of etoposide phosphate if required): 25 mg/m²/day in the evening orally every day fasting (capped to a maximum of 50 mg/day) First patient will be enrolled at dose level 1 2. nd stage: * Axitinib (Inlyta®) dosing as selected at the 1st stage * Etoposide (50 mg capsules or in the form of etoposide phosphate if required): 25 mg/m2/ day in the evening orally every day fasting(capped to a maximum of 50 mg/day)
Dose-limiting toxicity (DLT)
During first stage
Progression-free survival (PFS)
During second stage, progression-free survival (PFS) computed as the time interval from the beginning of treatment to the date of centrally-assessed with RAPNO criteria. A central review of all imaging is planned at the end of phase 1 and at the end of phase expansion to evaluate tumor response and progressions. PFS-duration of patients alive free of progression at last follow-up will be censored at the date of last visit.
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