No registrations found.
ID
Source
Brief title
Health condition
lungcancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in erlotinib bioavailability during coca-cola intake vs. water intake (+/- PPI)
Secondary outcome
Toxicity of erlotinib
Background summary
PPI use during Erlotinib therapy decreases bioavailability of the latter. Since a PPI is often used during erlotinib therapy, this DDI confronts pharmacists and oncologists with major challenges. A profound solution for managing this DDI is not yet available.
A possible (and practical) way to by-pass the DDI between erlotinib and PPIs is to temporarily lower the stomach pH by taking erlotinib with an acidic beverage, such as Coca-Cola (pH=2,8). 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.
Study objective
PPI use during Erlotinib therapy decreases bioavailability of the latter. Since a PPI is often used during erlotinib therapy, this DDI confronts pharmacists and oncologists with major challenges. A profound solution for managing this DDI is not yet available.
A possible (and practical) way to by-pass the DDI between erlotinib and PPIs is to temporarily lower the stomach pH by taking erlotinib with an acidic beverage, such as Coca-Cola (pH=2,8).
Study design
N.a.
Intervention
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.
Ron H.J. Mathijssen
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338, buzzer 229
a.mathijssen@erasmusmc.nl
Ron H.J. Mathijssen
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338, buzzer 229
a.mathijssen@erasmusmc.nl
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
Exclusion criteria
1. Age < 18 years
2. Pregnant or lactating patients
3. Impossibility to take oral drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4320 |
| NTR-old | NTR4540 |
| CCMO | NL47466.078.14 |
| OMON | NL-OMON40431 |