Pharmacokinetics and pharmacogenetics of anticancer drugs in infants and young children - Infant PK/PG

Phase 1

• Conditions: Any childhood cancer.

• Registration Number: EUCTR2006-002845-36-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-20
• Study Completion: 2014-09-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

a) Age <2 years at time of study registration.
b) Diagnosis of childhood cancer.
c) Receiving carboplatin, cyclophosphamide or etoposide as standard treatment.
d) Single or double lumen central venous catheter in place.
e) Written informed consent.
f) Protocol approval by national and local ethics committee, regulatory authority and NHS TRust R&D Departments.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Failure to comply with any of the inclusion criteria.

Receiving concomitant treatment with anticonvulsants, azole antifungal agents and chronic steroid treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study is designed to :-<br><br>•Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age <2 years on current dosing schedules.<br><br>•Compare drug exposures and degree of pharmacokinetic variability in children <2 years with data obtained from published studies in older children.<br><br>• Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response.<br><br>•Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants/young children. The feasibility and clinical value of pharmacologically-guided dosing in subsequent studies in this patient population will also be considered.<br>;Secondary Objective: ;Primary end point(s): Characterisation of the pharmacokinetics of carboplatin, cyclophosphamide and etoposide in children < 2yrs old.