Pharmacokinetics of- and interaction between aprepitant and dexamethasone
- Conditions
- Oncology
- Registration Number
- NL-OMON20649
- Lead Sponsor
- Princess Maxima Center for pediatric oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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;
Exclusion Criteria
See inclusion criteria
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to define the differences in the interaction between oral dexamethasone and aprepitant and the interaction between iv dexamethasone and aprepitant.
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to describe the PK of aprepitant and dexamethasone together with the results of an ongoing study in pediatric patients (in the Princess Maxima Center for pediatric oncology), to describe the age dependent differences in PK of dexamethasone and aprepitant.