lungcancer Non-small cell lung carcinoma
Conditions
Interventions
- in phase B: a low-fat diet, c.q. 200 grams low-fat yoghurt as breakfast, and
normal dinner
- in phase C: a normal diet with different intake times, c.q. lunch and dinner.
- in phase D: a normal diet, c.q. continental breakfast and dinner, with
co-administration of semaglutide 2.0 mg s.c..
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age: >=18 years; • Able to understand the written information and willing to give informed consent; • Diagnosed with metastatic NSCLC and (are planned to) receive treatment with alectinib (Alecensa); • Use of alectinib of at least 14 days, to guarantee steady-state, and expected to continue treatment until end of study period; • Willing to follow dietary restrictions.
Exclusion criteria
Exclusion criteria: • Unable to draw blood for study purposes; • Unwillingness to abstain from any other food or drinks than the prescribed restrictions 1 hour before and 2 hours after intake of alectinib at the pharmacokinetic sampling day; • Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria); • Allergic to compounds in yoghurt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Ctrough of alectinib in patients with NSCLC treated with alectinib when concomitantly taken with a continental breakfast, low-fat yoghurt as breakfast or at lunchtime. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The current food intake with alectinib; - The occurrence of patient-reported toxicity when alectinib is taken with a continental breakfast, a low fat diet and lunchtime; - A pharmacokinetic model of alectinib when alectinib is taken with a continental breakfast. - Analysis of a possible drug-drug interaction between alectinib and semaglutide. | — |
Countries
Netherlands
Outcome results
None listed