Influence of milk on erlotinib

Phase 1

• Conditions: ung cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001597-15-NL
• Lead Sponsor: Erasmus MC cancer institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-04
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)).<br>2.To evaluate the incidence and severity of side-effects of treatment with erlotinib in absence and presence of esomeprazole<br>;Timepoint(s) of evaluation of this end point: End of study