The effect of the acid-reducing drug esomeprazol on afatinib in lung cancer patients
Recruiting
- Conditions
- SCLC<br />non small cell lungcarcinoma<br />NKCLC<br />niet-kleincellig longcarcinoom
- Registration Number
- NL-OMON22493
- Lead Sponsor
- Erasmus MC Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
1. Age ≥ 18 years
2. Histological or cytological confirmed diagnosis of EGFR-mutated NSCLC
Exclusion Criteria
1. Pregnant or lactating patients.
2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration and time to Cmax). <br /><br>2. To evaluate the incidence and severity of side-effects of treatment with afatinib in absence and presence of esomeprazole.