Lung cancer
Conditions
Interventions
Trade Name: Tarceva
Product Name: Tarceva
Pharmaceutical Form: Tablet
Trade Name: Nexium
Product Name: Nexium
Pharmaceutical Form: Tablet
Sponsors
Erasmus MC cancer institute
Eligibility
Sex/Gender
All
Inclusion criteria
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) 3. Use of erlotinib monotherapy for at least 14 days (to guarantee steady-state) and willing to continue the treatment until the end of 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients 2. Impossibility to take oral drugs 3. Serious illness or medically unstable condition requiring treatment, symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To determine the influence of the fatty beverage Milk on the systemic exposure (AUC) to erlotinib in patients with or without concomitant use of a PPI. ;Secondary Objective: Secondary objectives: 1) other pharmacokinetic outcomes (i.e. clearance (CL), maximum concentration (Cmax) and time to Cmax (tmax)). 2) To compare the incidence and severity of side-effects of treatment with erlotinib in absence and presence of Milk.;Primary end point(s): 1. To determine the influence of the fatty beverage Milk, concomitantly taken with erlotinib alone, on erlotinib plasma pharmacokinetics (AUC) compared to erlotinib alone concomitantly taken with water in NSCLC patients. 2. To determine the influence of the fatty beverage 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. ;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 (Cmax) and time to Cmax (tmax)). 2. To evaluate the incidence and severity of side-effects of treatment with erlotinib in absence and presence of esomeprazole ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Contacts
Public ContactA.H.J. Mathijssen
Erasmus MC cancer institute
Outcome results
None listed