PHARMACOKINETICS OF APREPITANT, DEXAMETHASONE AND THEIR INTERACTION IN CHILDREN WITH CHEMOTHERAPY INDUCED NAUSEA AND VOMITING: A PILOT STUDY

Completed

• Conditions: pharmacokinetics of antiemetics for chemotherapy induced vomiting and nausea; 10027655; 10017947

• Registration Number: NL-OMON48783
• Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 99

Inclusion Criteria

1. Planned to receive chemotherapy intravenously as regular treatment (standard of care);
2. Receiving granisetron/ondansetron; dexamethasone and/or aprepitant as standard of care
3. Age * 6maanden en *19 years;
4. Informed consent form (ICF) signed prior to participation in the study;
5. A present central line to sample blood for pharmacokinetics;
6. No Down syndrome or other syndromes that may influence regular dosing or no other disease/circumstances that may influence the participation of the subject in a negative way;
7. No use of strong CYP3A4 substrates or inhibitors within 7 days or CYP3A4 inducers within 30 days of treatment (appendix 2);
8. No current pregnancy
9. During fertile age, extra none-hormonal contraceptives during the days of emend until 2 months after

Exclusion Criteria

see above, all described in the inclusion criteria

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Population PK model dexamethason/ aprepitant.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Feasibility PeNAT score on nausea intensity in clinical practice</p><br>