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Influence of an acidic beverage on the absorption of erlotinib


- candidate number17570
- NTR NumberNTR4540
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-apr-2014
- Secondary IDsNL47466.078.14 
- Public TitleInfluence of an acidic beverage on the absorption of erlotinib
- Scientific TitleInfluence of an acidic beverage on the absorption of erlotinib
- ACRONYMCOLA-study
- hypothesis 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).
- Healt Condition(s) or Problem(s) studiedLung cancer
- Inclusion criteria1. 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 criteria1. Age < 18 years
2. Pregnant or lactating patients
3. Impossibility to take oral drugs
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-apr-2014
- planned closingdate25-apr-2016
- Target number of participants28
- InterventionsTo 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.
- Primary outcomeDifferences in erlotinib bioavailability during coca-cola intake vs. water intake (+/- PPI)
- Secondary outcomeToxicity of erlotinib
- TimepointsN.a.
- Trial web siteN.a.
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD PhD Ron H.J. Mathijssen
- CONTACT for SCIENTIFIC QUERIES Roelof Leeuwen, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting De Merel
- Publicationsvan Leeuwen et al. Influence of the Acidic Beverage Cola on the Absorption of Erlotinib in Patients With Non-Small-Cell Lung Cancer. J Clin Oncol. 2016;34(12):1309-14
- Brief summaryPPI 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.
- Main changes (audit trail)
- RECORD25-apr-2014 - 12-okt-2016


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