{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:43:15Z","timestamp":1761864195541,"version":"3.44.0"},"reference-count":22,"publisher":"Elsevier BV","issue":"11","license":[{"start":{"date-parts":[[2020,11,1]],"date-time":"2020-11-01T00:00:00Z","timestamp":1604188800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,11,1]],"date-time":"2020-11-01T00:00:00Z","timestamp":1604188800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T00:00:00Z","timestamp":1601942400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","clinicaltherapeutics.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Clinical Therapeutics"],"published-print":{"date-parts":[[2020,11]]},"DOI":"10.1016\/j.clinthera.2020.09.015","type":"journal-article","created":{"date-parts":[[2020,11,1]],"date-time":"2020-11-01T08:45:11Z","timestamp":1604220311000},"page":"2214-2224","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":6,"title":["Potential Drug\u2013Drug Interactions with Combination Volasertib\u00a0+ Itraconazole: A Phase I, Fixed-sequence Study in Patients with Solid Tumors"],"prefix":"10.1016","volume":"42","author":[{"given":"Istvan","family":"Lang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Holger","family":"Fritsch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8990-576X","authenticated-orcid":false,"given":"Tillmann","family":"Taube","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evgenii","family":"Chizhikov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bela","family":"Liptai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.clinthera.2020.09.015_bib1","doi-asserted-by":"crossref","first-page":"3094","DOI":"10.1158\/1078-0432.CCR-08-2445","article-title":"BI 6727, a polo-like kinase inhibitor with improved pharmacokinetic profile and broad antitumor activity","volume":"15","author":"Rudolph","year":"2009","journal-title":"Clin Canc Res"},{"key":"10.1016\/j.clinthera.2020.09.015_bib2","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1038\/sj.onc.1200862","article-title":"Prognostic significance of polo-like kinase (PLK) expression in non-small cell lung cancer","volume":"14","author":"Wolf","year":"1997","journal-title":"Oncogene"},{"key":"10.1016\/j.clinthera.2020.09.015_bib3","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1038\/nrc1841","article-title":"Targeting polo-like kinase 1 for cancer therapy","volume":"6","author":"Strebhardt","year":"2006","journal-title":"Nat Rev Canc"},{"key":"10.1016\/j.clinthera.2020.09.015_bib4","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1111\/j.1349-7006.2003.tb01411.x","article-title":"Polo-like kinase 1 (PLK1) is overexpressed in primary colorectal cancers","volume":"94","author":"Takahashi","year":"2003","journal-title":"Canc Sci"},{"key":"10.1016\/j.clinthera.2020.09.015_bib5","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1159\/000094416","article-title":"Overexpression of polo-like kinase 1 (PLK1) and chromosomal instability in bladder cancer","volume":"70","author":"Yamamoto","year":"2006","journal-title":"Oncology"},{"key":"10.1016\/j.clinthera.2020.09.015_bib6","doi-asserted-by":"crossref","first-page":"1426","DOI":"10.1182\/blood-2014-03-560557","article-title":"Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy","volume":"124","author":"Dohner","year":"2014","journal-title":"Blood"},{"key":"10.1016\/j.clinthera.2020.09.015_bib7","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1007\/s10637-015-0223-9","article-title":"Phase I trial of volasertib, a polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity","volume":"33","author":"Awada","year":"2015","journal-title":"Invest New Drugs"},{"key":"10.1016\/j.clinthera.2020.09.015_bib8","doi-asserted-by":"crossref","first-page":"843","DOI":"10.1007\/s00280-015-2860-2","article-title":"A\u00a0phase I study of volasertib combined with afatinib, in advanced solid tumors","volume":"76","author":"Machiels","year":"2015","journal-title":"Canc Chemother Pharmacol"},{"key":"10.1016\/j.clinthera.2020.09.015_bib9","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1016\/j.ejca.2011.11.001","article-title":"A\u00a0phase I, dose-escalation study of the novel polo-like kinase inhibitor volasertib (BI 6727) in patients with advanced solid tumours","volume":"48","author":"Schoffski","year":"2012","journal-title":"Eur J Canc"},{"key":"10.1016\/j.clinthera.2020.09.015_bib10","doi-asserted-by":"crossref","first-page":"2434","DOI":"10.1038\/bjc.2014.195","article-title":"A\u00a0phase I study of two dosing schedules of volasertib (BI 6727), an intravenous polo-like kinase inhibitor, in patients with advanced solid malignancies","volume":"110","author":"Lin","year":"2014","journal-title":"Br J Canc"},{"key":"10.1016\/j.clinthera.2020.09.015_bib11","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1007\/s10637-015-0300-0","article-title":"Phase I trial of volasertib, a polo-like kinase inhibitor, in Japanese patients with advanced solid tumors","volume":"34","author":"Nokihara","year":"2016","journal-title":"Invest New Drugs"},{"key":"10.1016\/j.clinthera.2020.09.015_bib12","doi-asserted-by":"crossref","first-page":"1018","DOI":"10.1111\/bjh.15204","article-title":"Phase I dose-escalation trial investigating volasertib as monotherapy or in combination with cytarabine in patients with relapsed\/refractory acute myeloid leukaemia","volume":"184","author":"Ottmann","year":"2019","journal-title":"Br J Haematol"},{"key":"10.1016\/j.clinthera.2020.09.015_bib13","doi-asserted-by":"crossref","first-page":"1590","DOI":"10.1111\/cas.12814","article-title":"Phase I trial of volasertib, a polo-like kinase inhibitor, in Japanese patients with acute myeloid leukemia","volume":"106","author":"Kobayashi","year":"2015","journal-title":"Canc Sci"},{"key":"10.1016\/j.clinthera.2020.09.015_bib14","doi-asserted-by":"crossref","first-page":"976","DOI":"10.1002\/cncr.28519","article-title":"An open-label, single-arm, phase 2 trial of the polo-like kinase inhibitor volasertib (BI 6727) in patients with locally advanced or metastatic urothelial cancer","volume":"120","author":"Stadler","year":"2014","journal-title":"Cancer"},{"key":"10.1016\/j.clinthera.2020.09.015_bib15","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1007\/s40262-017-0566-9","article-title":"Population pharmacokinetics of volasertib administered in patients with acute myeloid leukaemia as a single agent or in combination with cytarabine","volume":"57","author":"Solans","year":"2018","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.clinthera.2020.09.015_bib16","doi-asserted-by":"crossref","first-page":"111","DOI":"10.2165\/00003088-200038020-00002","article-title":"Effects of the antifungal agents on oxidative drug metabolism: clinical relevance","volume":"38","author":"Venkatakrishnan","year":"2000","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.clinthera.2020.09.015_bib17","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1208\/s12248-009-9103-6","article-title":"Prediction of hepatic clearance in human from in\u00a0vitro data for successful drug development","volume":"11","author":"Chiba","year":"2009","journal-title":"AAPS J"},{"key":"10.1016\/j.clinthera.2020.09.015_bib18","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1111\/bcp.12668","article-title":"Ritonavir is the best alternative to ketoconazole as an index inhibitor of cytochrome P450-3A in drug-drug interaction studies","volume":"80","author":"Greenblatt","year":"2015","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.clinthera.2020.09.015_bib19","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1002\/jcph.562","article-title":"Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies","volume":"56","author":"Liu","year":"2016","journal-title":"J\u00a0Clin Pharmacol"},{"key":"10.1016\/j.clinthera.2020.09.015_bib20","article-title":"FDA drug safety communication:","author":"FDA","year":"2017","journal-title":"FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems"},{"key":"10.1016\/j.clinthera.2020.09.015_bib21","doi-asserted-by":"crossref","first-page":"2341","DOI":"10.1093\/annonc\/mdv354","article-title":"A\u00a0phase I, dose-escalation study of volasertib combined with nintedanib in advanced solid tumors","volume":"26","author":"de Braud","year":"2015","journal-title":"Ann Oncol"},{"key":"10.1016\/j.clinthera.2020.09.015_bib22","doi-asserted-by":"crossref","first-page":"706","DOI":"10.1200\/JCO.2015.62.1474","article-title":"Volasertib versus chemotherapy in platinum-resistant or -refractory ovarian cancer: a randomized phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study","volume":"34","author":"Pujade-Lauraine","year":"2016","journal-title":"J\u00a0Clin Oncol"}],"container-title":["Clinical Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0149291820304653?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0149291820304653?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T08:53:10Z","timestamp":1758963190000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0149291820304653"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11]]},"references-count":22,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["S0149291820304653"],"URL":"https:\/\/doi.org\/10.1016\/j.clinthera.2020.09.015","relation":{},"ISSN":["0149-2918"],"issn-type":[{"type":"print","value":"0149-2918"}],"subject":[],"published":{"date-parts":[[2020,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Potential Drug\u2013Drug Interactions with Combination Volasertib\u00a0+ Itraconazole: A Phase I, Fixed-sequence Study in Patients with Solid Tumors","name":"articletitle","label":"Article Title"},{"value":"Clinical Therapeutics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.clinthera.2020.09.015","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}]}}