TEMOkids study
Research type
Research Study
Full title
TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide
IRAS ID
290719
Contact name
Laurent Martin
Contact email
Sponsor organisation
ORPHELIA Pharma
Eudract number
2020-003733-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This is an european, multi-center, interventional, paediatric trial. \nThe objective of this study it to evaluate the fate in the body, acceptability and safety of Kimozo, a drinkable form of temozolomide adapted to children. \nMale and female patients aged 1 to less than 18 years and in need of temozolomide would be eligibile. \nThe objectif is to enrolle 40 patients in 15 european institutions. The expected study duration is 18 months. \nThe patient will be required to stay for one day at the hospital for the first day of treatment. A total of six blood samples of 1 mL (minimum 0.75 mL) will be drawn before and post first treatment for pharmacokinetics measurements. \n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
21/NW/0025
Date of REC Opinion
17 Mar 2021
REC opinion
Further Information Favourable Opinion