Trial Profile

TEMOkids Study: A Population Pharmacokinetic, Acceptability and Safety Study for KIMOZO, a Paediatric Oral Suspension of Temozolomide

Status: Active, no longer recruiting

Phase of Trial: Phase I

Latest Information Update: 30 Oct 2023

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At a glance

Drugs Temozolomide (Primary)
Indications Cancer; Ewing's sarcoma; Glioma; Medulloblastoma; Neuroblastoma; Rhabdomyosarcoma
Focus Pharmacokinetics; Registrational
Acronyms TEMOkids
Sponsors ORPHELIA Pharma

Most Recent Events

24 Oct 2023 According to an ORPHELIA Pharma media release, the company has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for KIZFIZO, the first oral liquid formulation of temozolomide.
07 Jul 2023 This trial has been completed in Germany (Global end date: 3 July 2023)
06 Mar 2023 This trial has been completed in Netherlands according to European Clinical Trials Database record.

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