{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T21:27:12Z","timestamp":1760909232885,"version":"3.40.5"},"reference-count":24,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,4,16]],"date-time":"2020-04-16T00:00:00Z","timestamp":1586995200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["836031010"],"award-info":[{"award-number":["836031010"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Taking advantage of its food\u2010dependent bioavailability, the present study investigated the effect of a reduced dose taken with real\u2010life meals on the pharmacokinetics (PK) of nilotinib in chronic myeloid leukaemia (CML) patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Nilotinib was taken fasted (300\u00a0mg BID, days 1\u20104) or with real\u2010life meals (200\u00a0mg BID, days 5\u201011). Rich sampling (days 1, 3, 8, 11) allowed for non\u2010compartmental PK analysis. Nilotinib exposure (AUC<jats:sub>0\u201312\u00a0h<\/jats:sub>\u00a0\u2010<jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub> \u2010<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) and its intra\u2010 and interpatient variability were compared between the two regimens. Adverse events were recorded by means of a patient diary and ECG monitoring.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifteen patients aged 40\u201074\u00a0years participated. Nilotinib PK following 200\u00a0mg BID taken with a meal strongly resembled that of 300\u00a0mg BID taken fasted (<jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub> percentile (P)10\u2010P90: 665\u20101404\u00a0ng\/mL and 557\u20101743\u00a0ng\/mL, respectively). Meals delayed nilotinib absorption. Intra\u2010 and interpatient variability were not increased by intake with meals. Nilotinib with food was well tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>With support of therapeutic drug monitoring, the use of a reduced 200\u00a0mg nilotinib dose with real\u2010life meals seems feasible and safe. Future (confirmatory) studies should further explore the usefulness of nilotinib dosing together with food, including the relationship with treatment efficacy as well as long\u2010term effects on quality of life.<\/jats:p><jats:p>Clinical Trial Registration: NTR5000 (Netherlands Trial Register, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.trialregister.nl\">www.trialregister.nl<\/jats:ext-link>).<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.13418","type":"journal-article","created":{"date-parts":[[2020,4,3]],"date-time":"2020-04-03T17:21:37Z","timestamp":1585934497000},"page":"148-155","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Food\u2010effect study of nilotinib in chronic myeloid leukaemia (NiFo study): Enabling dose reduction and relief of treatment burden"],"prefix":"10.1111","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0202-3612","authenticated-orcid":false,"given":"Christel C. L. M.","family":"Boons","sequence":"first","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Clinical Pharmacology and Pharmacy Cancer Centre Amsterdam Amsterdam The Netherlands"},{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Public Health Research Institute Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yvonne M.","family":"den Hartog","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Haematology Cancer Centre Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeroen J. W. M.","family":"Janssen","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Haematology Cancer Centre Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthe S.","family":"Zandvliet","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Clinical Pharmacology and Pharmacy Cancer Centre Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ren\u00e9 M.","family":"Vos","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Clinical Pharmacology and Pharmacy Cancer Centre Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleonora L.","family":"Swart","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Clinical Pharmacology and Pharmacy Cancer Centre Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N. Harry","family":"Hendrikse","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Clinical Pharmacology and Pharmacy Cancer Centre Amsterdam Amsterdam The Netherlands"},{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Radiology and Nuclear Medicine Cancer Centre Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacqueline G.","family":"Hugtenburg","sequence":"additional","affiliation":[{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Department of Clinical Pharmacology and Pharmacy Cancer Centre Amsterdam Amsterdam The Netherlands"},{"name":"Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Public Health Research Institute Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,4,16]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx219"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25011"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1609324"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.64.8899"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2016.5"},{"key":"e_1_2_9_7_1","unstructured":"Tasigna: European Public Assessment Report \u2010 Product Information.Annex I \u2010 Summary of product characteristics. 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