Effect of food on the pharmacokinetics of nilotinib in chronic myeloid leukemia: assessment of a tailored dose reduction (NiFo-study)
Completed
- Conditions
- Chronic Myeloid LeukemiaCancer of white blood cells.10024324
- Registration Number
- NL-OMON42074
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Male or female patients * 18 years of age
2. Chronic myeloïd leukemia in chronic phase
3. Currently treated with nilotinib at 300 mg bid for at least 3 months
4. Stable clinical status
5. Written informed consent
Exclusion Criteria
1. Patient is unable to fill out a patient diary
2. Patient has insufficient Dutch language skills
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in pharmacokinetic parameters AUC, Cmax, and Cmin between fasted<br /><br>and fed administration of nilotinib</p><br>
- Secondary Outcome Measures
Name Time Method <p>Inter- and intrapatient variability, patient reported side effects and quality<br /><br>of life</p><br>