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

NCT04610736 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

  • Pediatric Cancer

Interventions

DRUG

Temozolomide Oral Suspension

One prescribed oral dose (range 75 to 200 mg/m2) once daily for 5 days

Sponsors & Collaborators

  • ClinSearch

    collaborator OTHER

  • Orphelia Pharma

    lead INDUSTRY

Principal Investigators

  • Samuel Abbou, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610736 on ClinicalTrials.gov