The effects of the proton pump inhibitor esomeprazole on the bioavailability of afatinib (Giotrif®) in patients with non-small cell lung cancer (NSCLC) 'the BIO-GIO study'
- Conditions
- NSCLC or lungcancer10038666
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the area under the curve of afatinib compared to afatinib<br /><br>concomitantly used with esomeprazole and to afatinib used with esomeprazole 3<br /><br>hours prior in patients with non-small cell lung cancer.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration and<br /><br>time to Cmax).<br /><br>2. To evaluate the incidence and severity of side-effects of treatment with<br /><br>afatinib in absence and presence of esomeprazole.</p><br>