Effect van voedsel op de farmacokinetiek van nilotinib: op maat naar een lagere dosering (NiFo-onderzoek)

Effect of food on the pharmacokinetics of nilotinib in chronic myeloid leukemia: assessment of a tailored dose reduction (NiFo-study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23914

Enrollment

Registered

2015-02-20

Start date

2015-03-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Chronic Myeloid Leukemia Nilotinib

Interventions

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 variab

Eligibility

Inclusion criteria

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

Exclusion criteria: - Patient is unable to fill out a patient diary; - Patient has insufficient knowledge of the Dutch language.

Design outcomes

Primary

Measure	Time frame
The difference in pharmacokinetic parameters AUC, Cmax, and Cmin between fasted and fed administration of nilotinib.	—

Secondary

Measure	Time frame
Interpatient variability Intrapatient variability Patient-reported side effects Quality of life	—

Contacts

Public ContactJ.G. Hugtenburg

Clinical Pharmacology and Pharmacy VU University Medical Center PO Box 7057

jg.hugtenburg@vumc.nl00 31 20 4448090

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)