Effect van voedsel op de farmacokinetiek van nilotinib: op maat naar een lagere dosering (NiFo-onderzoek)
Completed
- Conditions
- Chronic Myeloid LeukemiaNilotinib
- Registration Number
- NL-OMON23914
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Male or female patients at least 18 years of age;
- Chronic Myeloid Leukemia in chronic phase;
- Currently treated with nilotinib at 300 mg bid for at least 3 months;
- Stable clinical status;
- Written informed consent.
Exclusion Criteria
- Patient is unable to fill out a patient diary;
- Patient has insufficient knowledge of the Dutch language.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in pharmacokinetic parameters AUC, Cmax, and Cmin between fasted and fed administration of nilotinib.
- Secondary Outcome Measures
Name Time Method Interpatient variability<br>Intrapatient variability<br>Patient-reported side effects<br>Quality of life