No registrations found.
ID
Source
Brief title
Health condition
Chronic Myeloid Leukemia
Nilotinib
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in pharmacokinetic parameters AUC, Cmax, and Cmin between fasted and fed administration of nilotinib.
Secondary outcome
Interpatient variability
Intrapatient variability
Patient-reported side effects
Quality of life
Background summary
Primary Objective: To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients.
Exploratory Objective: To evaluate patient reported side effects and quality of life of CML patients using nilotinib at a lowered dose of 200 mg bid, administered with a meal.
Study design: Intervention study with a pre-test post-test design, in chronic phase CML patients using nilotinib at a dose of 300 mg bid. The AUC, Cmax and Cmin of nilotinib, administered as recommended on an empty stomach during a period of four days, will be compared with the AUC, Cmax and Cmin of nilotinib 200 mg bid, administered with a meal for a period of seven days. Patient will be instructed about their meals. The study is non-invasive: nilotinib concentrations will be measured by means of the dried blood spot (DBS) sampling method. Patients will be asked to to complete a patient diary collecting data on the exact time of intake of nilotinib, exact time of blood sampling, consumption of food and side effects. Patients will be asked to fill out questions about quality of life. Overall study duration for the individual patient is 2 weeks.
Study objective
As food increases nilotinib bioavailability, intake of nilotinib with medium fat Dutch food is expected to increase the bioavailability to an extent that it will allow a reduction of the daily dose by about 30 percent. This both reduces costs substantially and allows for increased adherence to nilotinib simultaneously.
Study design
1. Bloodsampling
On day 1 and 3 of the four day period of fasted intake and on day 4 and 7 of the seven day period of fed intake: blood sampling at 1, 2, 3, 4, 6, 9 and 12 hrs after nilotinib intake in the morning, and 1, 2, 3 and 4 hrs after nilotinib intake in the evening and before the nilotinib intake of the next morning.
On day 1 of the seven day period of fed intake: blood sampling at 1, 2 and 3 hrs after nilotinib intake.
2. Questionnaire
At baseline and after the seven day period of fed intake.
3. Patient diary
On day 1 and 3 of the four day period of fasted intake and on day 1-7 of the seven day period of fed intake.
Intervention
Nilotinib at a lowered dose of 200 mg bid, administered with a meal for a period of seven days.
The half-life of nilotinib is 17 hrs, which suggests that variability in pharmacokinetics, due to variability in the composition of meals, is limited. However, for safety reasons and to get insight into the effect of a high fat meal, patients will be asked to take nilotinib once with a high fat meal, to be planned at day seven (evening intake) of the seven day period of fed intake. A dietician will assist patients to select meals that fit into these guidelines.
VU University Medical Center
PO Box 7057
J.G. Hugtenburg
Amsterdam 1007 MB
The Netherlands
00 31 20 4448090
jg.hugtenburg@vumc.nl
VU University Medical Center
PO Box 7057
J.G. Hugtenburg
Amsterdam 1007 MB
The Netherlands
00 31 20 4448090
jg.hugtenburg@vumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4898 |
NTR-old | NTR5000 |
CCMO | NL50637.029.15 |
OMON | NL-OMON42074 |