PHARMACOKINETICS OF APREPITANT AND DEXAMETHASONE
- Registration Number
- NL-OMON24991
- Lead Sponsor
- Princess Maxima Center for pediatric oncology
- Brief Summary
Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. The Lancet. Oncology. Apr 2015;16(4):385-394
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Planned to receive chemotherapy intravenously as regular treatment (standard of care);
Exclusion Criteria
see eligibility criteria above
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 recommended dose of aprepitant given in combination with dexamethasone by constructing a population PK model in children according to different age groups
- Secondary Outcome Measures
Name Time Method 1. The feasibility of using the validated PeNAT score on nausea intensity in clinical practice<br /><br>2. To describe possible interaction of dexamethasone and aprepitant with concurrent chemotherapy