PHARMACOKINETICS OF APREPITANT, DEXAMETHASONE AND THEIR INTERACTION IN PATIENTS WITH CHEMOTHERAPY INDUCED NAUSEA AND VOMITING

Recruiting

• Conditions: Chemotherapy induced vomiting and nausea; 10018012; 10027655

• Registration Number: NL-OMON52052
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Planned to receive chemotherapy intravenously as regular treatment (standard
of care);
2. Receiving dexamethasone with or without aprepitant as standard of care
3. Receiving the chemotherapy and anti-emetics during hospitalized treatment.
4. Age >=18;
5. Signed Informed consent form (ICF) prior to participation in the study;
6. Able and willing to undergo blood draw for the study (two different days, 6
times per day) and does not have any condition that makes participation
disadvantageous.
7. For women: not pregnant
8. No use of strong CYP3A4 substrates or inhibitors within 7 days or CYP3A4
inducers within 30 days of treatment (appendix 2);

Exclusion Criteria

See inclusion criteria

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic parameters (i.e. clearance and volume of distribution) will be<br /><br>assessed using non-linear mixed effects modelling (NONMEM). Influence of<br /><br>relevant co-variates will be assessed by standard model building methods.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>