Stuying the influence of milk on the absorption of erlotinib
Recruiting
- Conditions
- ongkanker , Lungcancer
- Registration Number
- NL-OMON20698
- Lead Sponsor
- Erasmus Medical Center
- 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 NSCLC, locally advanced and metastatic disease stage IIIB and IV, for which treatment with erlotinib monotherapy has been initiated (to be evaluated by the treating physician)
Exclusion Criteria
1. Pregnant or lactating patients
2. Impossibility to take oral drugs
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine the influence of the fatty beverage Cow’s milk, concomitantly taken with erlotinib alone, on erlotinib plasma pharmacokinetics (AUC) compared to erlotinib alone concomitantly taken with water in NSCLC patients.<br /><br>2. To determine the influence of the fatty beverage Cow’s milk, concomitantly taken with erlotinib and a PPI, on erlotinib plasma pharmacokinetics (AUC) compared to erlotinib and a PPI concomitantly taken with water in cancer patients.
- Secondary Outcome Measures
Name Time Method 1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)).<br /><br>2. To evaluate the incidence and severity of side-effects of treatment with erlotinib in absence and presence of esomeprazole