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Pharmacokinetics of- and interaction between aprepitant and dexamethasone

Pharmacokinetics of- and interaction between aprepitant and dexamethasone

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20649
Enrollment
20
Registered
2020-09-30
Start date
2020-11-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

Interventions

None listed

Sponsors

Princess Maxima Center for pediatric oncology
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: See inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactLaura Nijstad

UMC Utrecht

a.l.nijstad-2@umcutrecht.nl0887555555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)