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NCT04610736
TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide
Phase 1 trial testing Temozolomide Oral Suspension in Pediatric Cancer in 49 participants. Completed in 3 July 2023.
15 January 2023
Quick facts
| Lead sponsor | Orphelia Pharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 16 March 2021 |
| Primary completion | 15 January 2023 |
| Estimated completion | 3 July 2023 |
| Sites | 11 locations across France, Netherlands, United Kingdom, Germany, Spain |
Drugs / interventions tested
- Temozolomide Oral Suspension — full drug profile →
Conditions studied
- Pediatric Cancer — all drugs for Pediatric Cancer →
Sponsor
Orphelia Pharma — full company profile →
Who can join
Adults 1 to 17, any sex, with Pediatric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules.
Ducray F, Ramirez C, Robert M, Fontanilles M, et al · · 2023 · cited 1× · PMID 38140005 · DOI 10.3390/pharmaceutics15122664 -
Dispensing Oral Temozolomide in Children: Precision and Stability of a Novel and Ready to Use Liquid Formulation in Comparison with Capsule Derived Mixtures.
Lemarchand C, Bienaymé H, Rieutord A, Abbou S, et al · · 2023 · PMID 38140052 · DOI 10.3390/pharmaceutics15122711
Verify or expand the search:
- PubMed search for NCT04610736
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Orphelia Pharma trials
Trials by the same sponsor.
- NCT04467346 — Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules · Phase 1 · completed
- NCT04468282 — Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administra · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04610736 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Orphelia Pharma
- Last refreshed: 31 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04610736.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing