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Serial blood samples were collected with and without rucaparib for pharmacokinetic analysis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Thirty-six patients (<jats:italic>n<\/jats:italic>\u2009=\u200918 each arm) were enrolled and received at least 1 dose of study drug. In the drug\u2013drug interaction analysis (<jats:italic>n<\/jats:italic>\u2009=\u200915 each arm), the geometric mean ratio (GMR) of maximum concentration (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) with and without rucaparib was 1.29 for rosuvastatin, 1.09 for ethinylestradiol, and 1.19 for levonorgestrel. GMR of area under the concentration\u2013time curve from time zero to last quantifiable measurement (AUC<jats:sub>0\u2013last<\/jats:sub>) was 1.34 for rosuvastatin, 1.43 for ethinylestradiol, and 1.56 for levonorgestrel. There was no increase in frequency of treatment-emergent adverse events (TEAEs) when rucaparib was given with either of the probe drugs. In both arms, most TEAEs were mild in severity and considered unrelated to study treatment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Rucaparib 600\u00a0mg BID weakly increased the plasma exposure to rosuvastatin or oral contraceptives. Rucaparib safety profile when coadministered with rosuvastatin or oral contraceptives was consistent with that of rucaparib monotherapy. Dose adjustments of rosuvastatin and oral contraceptives are not necessary when coadministered with rucaparib.<\/jats:p>\n                <jats:p><jats:bold>ClinicalTrials.gov<\/jats:bold> NCT03954366; <jats:bold>Date of registration<\/jats:bold> May 17, 2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00280-021-04338-7","type":"journal-article","created":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T06:02:46Z","timestamp":1628488966000},"page":"887-897","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A phase 1, open-label, drug\u2013drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors"],"prefix":"10.1007","volume":"88","author":[{"given":"Mingxiang","family":"Liao","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krzysztof G.","family":"Jeziorski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monika","family":"Tomaszewska-Kiecana","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Istv\u00e1n","family":"L\u00e1ng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marek","family":"Jasi\u00f3wka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Viera","family":"Skarbov\u00e1","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piotr","family":"Centkowski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rodryg","family":"Ramlau","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"G\u00f3rna\u015b","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenn","family":"Habeck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eileen","family":"Nash","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikolay","family":"Grechko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3632-2012","authenticated-orcid":false,"given":"Jim J.","family":"Xiao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,8,9]]},"reference":[{"key":"4338_CR1","doi-asserted-by":"publisher","DOI":"10.1158\/1538-7445.AM2017-2475","author":"L Robillard","year":"2017","unstructured":"Robillard L, Nguyen M, Harding TC, Simmons AD (2017) In vitro and in vivo assessment of the mechanism of action of the PARP inhibitor rucaparib. 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EN has served in a consulting or advisory role for Bay Trials Unlimited, LLC. ML, JL, SE, JH, NG, and JX are employees of Clovis Oncology and may own stock or have stock options in that company. KGJ, MT-K, IL, MJ, VS, PC, and MG declare no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study protocol was approved by the Independent Ethics Committee of each institution. The study was conducted in compliance with the International Council for Harmonization Guideline for Good Clinical Practice, Food and Drug Administration regulatory requirements, and the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients signed the informed consent forms prior to entering the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All authors gave consent for publication.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}