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Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

One prescribed oral dose (range 75 to 200 mg/m2) once daily for 5 days

Temozolomide Oral Suspension

Samuel Abbou, MD

Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

The TEMOkids study is an international open-label, non-randomized, prospective, single-arm phase 1 study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

Patients will be subject to at least one 21 or 28-day treatment cycle involving administration of an oral suspension of temozolomide (KIMOZO) for five consecutive days followed by 16 or 23-days resting period, with determination of the PK parameters on the first treatment day.

Five (5) additional cycles will be allowed under compassionate use regimen. The compassionate use period could be extended at the discretion of the investigator and in agreement with the sponsor. Safety and activity data will be collected during the compassionate follow-up period.

The study will be held in multiple sites spread across Europe.

Non-randomized, international, multi-centre, open-label, single arm study

TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide

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

Estimated by a population analysis performed with NONMEM (7.4)

Scoring with a standardized assessment tool: CAST - ClinSearch Acceptability Score Test®. This tool measures 9 observational drivers of drug acceptability.

Adverse events collected directly by investigators when patient is hospitalized and through patient diary completed by caregivers and medically controlled by investigators when patient is at home

Activity assessment (complete or partial response, stable disease, disease progression)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide	NCT04610736	Pediatric Cance...	Temozolomide Or...	1 Year - 17 Years	Orphelia Pharma
TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide	NCT04610736	Pediatric Cance...	Temozolomide Or...	1 Year - 17 Years	Orphelia Pharma

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