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…
ID
Bron
Verkorte titel
Aandoening
lungcancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Differences in erlotinib bioavailability during coca-cola intake vs. water intake (+/- PPI)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
N.a.
Onderzoeksproduct en/of interventie
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.
Publiek
Ron H.J. Mathijssen
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338, buzzer 229
a.mathijssen@erasmusmc.nl
Wetenschappelijk
Ron H.J. Mathijssen
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041338, buzzer 229
a.mathijssen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 18 years
2. Pregnant or lactating patients
3. Impossibility to take oral drugs
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4320 |
| NTR-old | NTR4540 |
| CCMO | NL47466.078.14 |
| OMON | NL-OMON40431 |