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We conducted this phase I study to determine the safety of concurrent curcumin and irinotecan administration. Ten participants with advanced solid tumors received one of four doses (1,\u00a02, 3, and 4\u00a0g) of a curcumin phosphatidylcholine complex (PC) orally daily, and 200\u00a0mg\/m<jats:sup>2<\/jats:sup> of i.v. infusion irinotecan on days 1 and 15 of a 28\u2010day cycle, to determine the maximum tolerated dose (MTD) of PC. Thirteen participants received 4\u00a0g of PC (MTD) to assess the effect on the pharmacokinetic (PK) properties of irinotecan and its metabolites, SN\u201038 and SN\u201038G. Irinotecan, SN\u201038, and SN\u201038G exposure equivalence with and without curcumin was assessed using area under the plasma concentration\u2010time curves from 0 to 6\u00a0h (AUC<jats:sub>0\u20106h<\/jats:sub>). Safety assessments and disease responses were also evaluated. The combination of irinotecan and PC was well\u2010tolerated. Because there was no dose limiting toxicity, the maximum dose administered (4\u00a0g) was defined as the recommended phase II dose of PC. PC did not significantly alter the plasma exposure and other PK properties of irinotecan and its metabolites. There was no apparent increase in the incidence of irinotecan\u2010associated toxicities. The objective response rate was 3\/19 (22%, 95% confidence interval [CI]: 5\u201339%), median progression free survival and overall survival (<jats:italic>n<\/jats:italic>\u00a0=\u00a023) were 4\u00a0months (95% CI: 2.9\u20138.9\u00a0months) and 8.4\u00a0months (95% CI: 3.7 \u2013 not evaluable [NE]), respectively. Future studies are required to evaluate the efficacy of this combination.<\/jats:p>","DOI":"10.1111\/cts.13250","type":"journal-article","created":{"date-parts":[[2022,2,14]],"date-time":"2022-02-14T18:45:45Z","timestamp":1644864345000},"page":"1304-1315","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["A phase I evaluation of the effect of curcumin on dose\u2010limiting toxicity and pharmacokinetics of irinotecan in participants with solid tumors"],"prefix":"10.1111","volume":"15","author":[{"given":"Olumide B.","family":"Gbolahan","sequence":"first","affiliation":[{"name":"Division of Hematology and Oncology University of Alabama School of Medicine University of Alabama at Birmingham  Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bert H.","family":"O\u2019Neil","sequence":"additional","affiliation":[{"name":"Community North Cancer Center  Indianapolis Indiana 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