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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orphelia Pharma
• Collaborator: ClinSearch
• Treatments: Temozolomide

Criteria

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