NSCLC or lungcancer
Conditions
Interventions
Esomeprazole 40mg once daily, in a total of 10 days. Afatinib is taken in
accordance to standard of care. Esomeprazole will be taken concomitant and 3
hours prior afatanib intake, each period for 5
Afatinib
Esomeprazole
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Histological or cytological confirmed diagnosis of EGFR-mutated NSCLC 3. WHO Performance Status
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients. 2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria) 3. Known serious illness or medical unstable conditions that could interfere with this study; requiring treatment (e.g. infection, bleedings, uncontrolled hypertension despite optimal medical management, HIV, hepatitis, organ transplants, kidney, cardiac and respiratory diseases). 4. Unwillingness to abstain from acid beverages such as orange juice and cola in the morning during afatinib treatment in this study. 5. Patients who are clinical dependent of use of PPIs or other acid reducing drugs, e.g. due to elevated risk for gastro-intestinal bleeding.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration and time to Cmax). 2. To evaluate the incidence and severity of side-effects of treatment with afatinib in absence and presence of esomeprazole. | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the area under the curve of afatinib compared to afatinib concomitantly used with esomeprazole and to afatinib used with esomeprazole 3 hours prior in patients with non-small cell lung cancer. | — |
Countries
The Netherlands
Outcome results
None listed