cola-study

Conditions: ung cancer
MedDRA version: 16.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-003603-19-NL

Lead Sponsor: Erasmus University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age = 18 years
2. Use of Erlotinib monotherapy for at least 4 weeks
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Age < 18 years
2. Pregnant or lactating patients
3. Impossibility to take oral drugs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the influence of the acidic beverage Coca-Cola, concomitantly taken with erlotinib, on erlotinib plasma pharmacokinetics compared to erlotinib concomitantly taken with water in cancer patients;Secondary Objective: To compare the incidence and severity of side-effects of treatment with erlotinib in absence and presence of Coca-Cola;Primary end point(s): To determine the influence of the acidic beverage Coca-Cola, concomitantly taken with erlotinib (with or without a PPI), on erlotinib plasma pharmacokinetics compared to erlotinib concomitantly taken with water in cancer patients.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To compare the incidence and severity of side-effects of treatment with erlotinib in absence and presence of Coca-Cola;Timepoint(s) of evaluation of this end point: 12 months