NCT04610736

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Orphelia Pharma · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	Temozolomide Oral Suspension	One prescribed oral dose (range 75 to 200 mg/m2) once daily for 5 days

Timeline

• Start date: 2021-03-16
• Primary completion: 2023-01-15
• Completion: 2023-07-03
• First posted: 2020-10-30
• Last updated: 2025-07-31

Locations

11 sites across 5 countries: France, Germany, Netherlands, Spain, United Kingdom