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drugset / Trial / NCT04610736

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

NCT04610736 ↗

Phase 1 Completed 49 enrolled Orphelia Pharma ClinSearch · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-03-16
Primary completion
2023-01-15
Completion
2023-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 75 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications

childhood malignant neoplasm