NL-OMON48783CompletedNot Applicable
PHARMACOKINETICS OF APREPITANT, DEXAMETHASONE AND THEIR INTERACTION IN CHILDREN WITH CHEMOTHERAPY INDUCED NAUSEA AND VOMITING: A PILOT STUDY - Pharmacokinetics of aprepitant and dexamethasone
Prinses Máxima Centrum voor Kinderoncologie0 sites99 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 99
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2 to 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
Investigators
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