Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485908
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Axitinib and Oral Metronomic Etoposide for Pediatric Children and AYA RefractoryRelapsing Medulloblastoma and Ependymoma
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
MEPENDAX Phase III Study of Axitinib Inlyta and Oral Metronomic Etoposide for Pediatric Children and AYA RefractoryRelapsing Medulloblastoma and Ependymoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEPENDAX
Brief Summary:
It is an open multicentric phase III 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 wont be included in the second stage
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 wont be included in the second stage
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None