drugset / Trial / NCT06485908
Axitinib and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-10
- Primary completion
- 2026-04
- Completion
- 2030-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axitinib | Small molecule | 1.2 mg/m2 | Oral |
| Subject | Axitinib | Small molecule | 1.6 mg/m2 | Oral |
| Subject | Axitinib | Small molecule | 2 mg/m2 | Oral |
| Subject | Axitinib | Small molecule | 2.4 mg/m2 | Oral |
| Subject | Etoposide | Small molecule | 25 mg/m2 | Oral |