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cola-study

Influence of an acidic beverage on the absorption of erlotinib - COLA-study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-003603-19-NL
Enrollment
Unknown
Registered
2014-02-05
Start date
2014-03-11
Completion date
Unknown
Last updated
2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer MedDRA version: 16.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Tarceva Product Name: Tarceva Product Code: L01XE03 Pharmaceutical Form: Tablet INN or Proposed INN: ERLOTINIB HYDROCHLORIDE CAS Number: 183319-69-9 Current Sponsor code: Erlotinib_cola Ot

Sponsors

Erasmus University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Netherlands

Contacts

Public ContactRoelof van Leeuwen

Erasmus University Medical Centre

31107033202

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026