Clinical trial · Interventional
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
NCT04610736CI-TRIAL-00092918completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide Oral Suspension | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Temozolomide 40 mg/ml, Oral suspension
- interventionNames
- Drug: Temozolomide Oral Suspension
Primary outcomes (3)
- measure
- Population Phamacokinetic parameter: AUC24
- timeFrame
- At Day 1 of treatment cycle 1 (each cycle is 21 or 28 days) with post-dose samples collected at about 0.15, 0.5, 1, 2.5, and 7 hours post dose
- description
- Estimated by a population analysis performed with NONMEM (7.4)
- measure
- Population Phamacokinetic parameter: Cmax
- timeFrame
- At Day 1 of treatment cycle 1 (each cycle is 21 or 28 days) with post-dose samples collected at about 0.15, 0.5, 1, 2.5, and 7 hours post dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients in need of temozolomide (all indications with 5-day treatment per 21- or 28-day cycle). * Male and female patients aged 1 to less than 18 years * Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent. * Patients having records of coverage by a health insurance * Life expectancy ≥ 3 months * Adequate haematological function: * haemoglobin ≥ 80 g/L (transfusion support authorized) * neutrophil count ≥ 1.0 x 10e9 cells/L * platelet count ≥ 100 x 10e9 cells/L (without transfusion support) * in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/L and platelets ≥75 x 10e9 cells/L * Adequate renal function: * Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula \[1\] or its modified form \[2\] * Adequate hepatic function: * bilirubin ≤1.5 x ULN * AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases) * Lansky Score ≥ 70% Exclusion Criteria: * Patients who are co-administrated at day one with sodium valproate as it decreases the clearance of temozolomide * Patients with (naso)gastric tube administration of temozolomide during first cycle of treatment. * Patients already enrolled in studies investigating temozolomide or other investigational new drugs. * A post-menarche female with a positive blood/urine pregnancy test at inclusion. * Known contraindication or hypersensitivity to temozolomide or any chemically close substance
References
Publications (0)
Data not yet available
No reference posted for this study.