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Stuying the influence of milk on the absorption of erlotinib


- candidate number25679
- NTR NumberNTR6148
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-dec-2016
- Secondary IDsMEC-2016-590 METC Erasmus MC Rotterdam
- Public TitleStuying the influence of milk on the absorption of erlotinib
- Scientific TitleInfluence of a fatty beverage (Milk) on the absorption of erlotinib: a randomized, cross-over pharmacokinetic study (MERLOT-study)
- ACRONYMMERLOT
- hypothesisTo determine the influence of the fatty beverage Cow’s milk on the systemic exposure (AUC) to erlotinib in patients with or without concomitant use of a PPI.
- Healt Condition(s) or Problem(s) studiedLung cancer
- Inclusion criteria1. Age ≥ 18 years
2. Histological or cytological confirmed diagnosis of NSCLC, locally advanced and metastatic disease stage IIIB and IV, for which treatment with erlotinib monotherapy has been initiated (to be evaluated by the treating physician)
3. Use of erlotinib monotherapy for at least 14 days (to guarantee steady-state) and willing to continue the treatment until the end of the study
4. ECOG Performance Status ≤ 1
5. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
6. No concurrent use of (over the counter) medication or (herbal) supplements known to induce or inhibit CYP3A4, CYP2C8, CYP1A1, CYP2D6, and/or P-glycoprotein
7. No concurrent (over the counter) use of other acid reducing drugs other than esomeprazole 40mg (PPIs, H2As and/or antacids) during the study. Willing to switch to brand name esomeprazole (Nexium®) during the study if on other acid reducing drugs.
8. No concurrent medication or supplements which can interact with esomeprazole or erlotinib
9. Abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study
10. Willing to take erlotinib with Cow’s milk.
- Exclusion criteria1. Pregnant or lactating patients
2. Impossibility to take oral drugs
3. Serious illness or medically unstable condition requiring treatment, symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
4. Patients with proved lactose intolerance and/or cow’s milk protein intolerance.
5. Use of medications or dietary supplements known to induce or inhibit CYP3A4, CYP2C8, CYP1A1, CYP2D6, and/or P-glycoprotein
6. Unwillingness to abstain from acidic beverages (cola), grapefruit (juice), (herbal) dietary supplements, herbals, over-the-counter medication (except for paracetamol and ibuprofen) and other drugs known to seriously interact with esomeprazole and erlotinib during the study period.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytype[default]
- planned startdate 27-dec-2016
- planned closingdate1-jan-2018
- Target number of participants28
- Interventions1. Erlotinib intake with milk vs erlotinib intake with water
2. Erlotinib intake with milk + PPI vs erlotinib intake with water + PPI
- Primary outcome1. To determine the influence of the fatty beverage Cow’s milk, concomitantly taken with erlotinib alone, on erlotinib plasma pharmacokinetics (AUC) compared to erlotinib alone concomitantly taken with water in NSCLC patients.
2. To determine the influence of the fatty beverage Cow’s milk, concomitantly taken with erlotinib and a PPI, on erlotinib plasma pharmacokinetics (AUC) compared to erlotinib and a PPI concomitantly taken with water in cancer patients.
- Secondary outcome1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)).
2. To evaluate the incidence and severity of side-effects of treatment with erlotinib in absence and presence of esomeprazole
- TimepointsPK days will be on day 21 and 28 following after administration of erlotinib with milk or water during 7 days.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Koen (G.A.M.) Hussaarts
- CONTACT for SCIENTIFIC QUERIES Koen (G.A.M.) Hussaarts
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryIn this study we want to determine the influence of the fatty beverage Cow’s milk on the erlotinib absorption compared to erlotinib intake with water in NSCLC patients with or without a PPI.
- Main changes (audit trail)
- RECORD21-dec-2016 - 29-jan-2017


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