Non small cell lung cancer
Conditions
Interventions
Trade Name: afatinib
Pharmaceutical Form: Coated tablet
Trade Name: esomeprazole
Pharmaceutical Form: Gastro-resistant capsule
Sponsors
Erasmus MC Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Histological or cytological confirmed diagnosis of EGFR-mutated NSCLC 3. WHO Performance Status = 1 4. Able and willing to sign the Informed Consent Form prior to screening evaluations 5. No concurrent (over the counter) use of other acid reducing drugs (PPIs, H2As and/or antacids), other than esomeprazole 40mg once daily during the study. 6. No concurrent medication or supplements which can interact with esomeprazole or afatinib during the study period (such as PgP-inhibitors/inducers). 7. Abstain from grapefruit, grapefruit juice, herbal dietary supplements, cranberry juice, and herbal tea during the study period. 8. Adequate baseline patient characteristics (complete blood count, and serum biochemistry which involves sodium, calcium, potassium, creatinin, calculation of creatinin clearance (MDRD), AST, ALT, gamma-GT, lactate dehydrogenase (LDH), total bilirubin, albumin, glucose within two weeks prior to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
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
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 end point(s): 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.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactRon Mathijssen
Erasmus MC
Outcome results
None listed