NCT06485908

Axitinib and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma

MEPENDAX: Phase I/II Study of Axitinib (Inlyta®) and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 4 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Medulloblastoma
• Ependymoma

Interventions

Type	Name	Description
DRUG	administration of axitinib in combination with etoposide	1. 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)

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-04-01
• Completion: 2030-01-01
• First posted: 2024-07-03
• Last updated: 2024-07-03