{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T02:07:47Z","timestamp":1780106867592,"version":"3.54.0"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T00:00:00Z","timestamp":1780099200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T00:00:00Z","timestamp":1780099200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"National Institute of Oncology"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cancer Chemother Pharmacol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The phase 1, randomized, open-label, two-way crossover FEEL study assessed the effect of food on the pharmacokinetics of DHP107, an oral paclitaxel with a novel lipid formulation designed to be systemically absorbed without Cremophor EL, in patients with advanced solid tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients were randomized 1:1 to DHP107 (200 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      orally twice daily on Days 1, 8, 15 every 28 days for two cycles) treatment sequences: fasted\u2013fed (first DHP107 dose administered after overnight fast;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200913) and fed\u2013fasted (first DHP107 dose administered after a high-fat meal;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200912). The primary objective was to evaluate the effect of food on DHP107 pharmacokinetics. The secondary objective was DHP107 safety; efficacy was also assessed (both in all patients regardless of dosing sequence).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Mean systemic exposures were similar for paclitaxel and its metabolites under fed and fasted conditions. Geometric mean ratios (fed:fasted) for paclitaxel were: maximum concentration (C\n                      <jats:sub>max<\/jats:sub>\n                      ), 101.00% (95% CI 91.93\u2013110.95%); area under the curve (AUC\n                      <jats:sub>0\u201372<\/jats:sub>\n                      ), 102.92% (95% CI 95.04\u2013111.45%); and AUC\n                      <jats:sub>0\u2013inf<\/jats:sub>\n                      104.76% (95% CI 96.44\u2013113.80%), meeting criteria for no food effect. Common adverse events across the study period included diarrhea (fasted\u2013fed 61.5%; fed\u2013fasted 41.7%), vomiting (fasted\u2013fed 30.8%; fed\u2013fasted 8.3%), and neutropenia (fasted\u2013fed 23.1%; fed\u2013fasted 16.7%). Two fed\u2013fasted patients (16.7%) had partial responses and six had stable disease (50.0%); seven fasted\u2013fed patients had stable disease (53.8%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study suggests that the pharmacokinetics of DHP107 are unaffected by food and DHP107 can be taken with or without food.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov ID: NCT04675528; 107CS-7.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00280-026-04887-9","type":"journal-article","created":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T01:02:34Z","timestamp":1780102954000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study"],"prefix":"10.1007","volume":"96","author":[{"given":"Erika","family":"Hitre","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Istv\u00e1n","family":"L\u00e1ng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D\u00e9nes","family":"P\u00e1ll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,30]]},"reference":[{"issue":"18","key":"4887_CR1","doi-asserted-by":"publisher","first-page":"2677","DOI":"10.1091\/mbc.E14-04-0916","volume":"25","author":"BA Weaver","year":"2014","unstructured":"Weaver BA (2014) How taxol\/paclitaxel kills cancer cells. Mol Biol Cell 25(18):2677\u20132681. https:\/\/doi.org\/10.1091\/mbc.E14-04-0916","journal-title":"Mol Biol Cell"},{"issue":"4","key":"4887_CR2","doi-asserted-by":"publisher","first-page":"1959","DOI":"10.18632\/aging.203919","volume":"14","author":"S Lin","year":"2022","unstructured":"Lin S, Peng T, Meng Y, Cao C, Gao P, Wu P, Zhi W, Wei Y, Chu T, Liu B, Wei J, Huang X, Ding W, Cheng C (2022) Comparison of one-week versus three-week paclitaxel for advanced pan-carcinomas: systematic review and meta-analysis. Aging (Albany N Y) 14(4):1959\u20131982. https:\/\/doi.org\/10.18632\/aging.203919","journal-title":"Aging (Albany N Y)"},{"issue":"9210","key":"4887_CR3","doi-asserted-by":"publisher","first-page":"1176","DOI":"10.1016\/s0140-6736(00)02074-2","volume":"355","author":"J Crown","year":"2000","unstructured":"Crown J, O\u2019Leary M (2000) The taxanes: an update. Lancet 355(9210):1176\u20131178. https:\/\/doi.org\/10.1016\/s0140-6736(00)02074-2","journal-title":"Lancet"},{"issue":"7","key":"4887_CR4","doi-asserted-by":"publisher","first-page":"1263","DOI":"10.1200\/jco.1990.8.7.1263","volume":"8","author":"RB Weiss","year":"1990","unstructured":"Weiss RB, Donehower RC, Wiernik PH, Ohnuma T, Gralla RJ, Trump DL, Baker JR Jr., Van Echo DA, Von Hoff DD, Leyland-Jones B (1990) Hypersensitivity reactions from taxol. J Clin Oncol 8(7):1263\u20131268. https:\/\/doi.org\/10.1200\/jco.1990.8.7.1263","journal-title":"J Clin Oncol"},{"issue":"13","key":"4887_CR5","doi-asserted-by":"publisher","first-page":"1590","DOI":"10.1016\/S0959-8049(01)00171-X","volume":"37","author":"H Gelderblom","year":"2001","unstructured":"Gelderblom H, Verweij J, Nooter K, Sparreboom A (2001) Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J cancer (Oxford England: 1990) 37(13):1590\u20131598. https:\/\/doi.org\/10.1016\/S0959-8049(01)00171-X","journal-title":"Eur J cancer (Oxford England: 1990)"},{"key":"4887_CR6","unstructured":"Pfizer Inc (2024) Paclitaxel injection, USP dosage and administration. https:\/\/www.pfizermedicalinformation.com\/paclitaxel. Accessed May 23 2025"},{"issue":"2","key":"4887_CR7","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1177\/10781552231208978","volume":"30","author":"S Wile\u0144ski","year":"2024","unstructured":"Wile\u0144ski S, Koper A, \u015aledzi\u0144ska P, Bebyn M, Koper K (2024) Innovative strategies for effective paclitaxel delivery: Recent developments and prospects. J Oncol Pharm Pract 30(2):367\u2013384. https:\/\/doi.org\/10.1177\/10781552231208978","journal-title":"J Oncol Pharm Pract"},{"issue":"12 Pt 1","key":"4887_CR8","doi-asserted-by":"publisher","first-page":"3239","DOI":"10.1158\/1535-7163.Mct-07-0261","volume":"6","author":"JW Hong","year":"2007","unstructured":"Hong JW, Lee IH, Kwak YH, Park YT, Sung HC, Kwon IC, Chung H (2007) Efficacy and tissue distribution of DHP107, an oral paclitaxel formulation. Mol Cancer Ther 6(12 Pt 1):3239\u20133247. https:\/\/doi.org\/10.1158\/1535-7163.Mct-07-0261","journal-title":"Mol Cancer Ther"},{"issue":"1","key":"4887_CR9","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1038\/aps.2016.105","volume":"38","author":"Y Jang","year":"2017","unstructured":"Jang Y, Chung HJ, Hong JW, Yun C-W, Chung H (2017) Absorption mechanism of DHP107, an oral paclitaxel formulation that forms a hydrated lipidic sponge phase. Acta Pharmacol Sin 38(1):133\u2013145. https:\/\/doi.org\/10.1038\/aps.2016.105","journal-title":"Acta Pharmacol Sin"},{"issue":"5","key":"4887_CR10","doi-asserted-by":"publisher","first-page":"1220","DOI":"10.1093\/annonc\/mdy055","volume":"29","author":"YK Kang","year":"2018","unstructured":"Kang YK, Ryu MH, Park SH, Kim JG, Kim JW, Cho SH, Park YI, Park SR, Rha SY, Kang MJ, Cho JY, Kang SY, Roh SY, Ryoo BY, Nam BH, Jo YW, Yoon KE, Oh SC (2018) Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy. Ann Oncol 29(5):1220\u20131226. https:\/\/doi.org\/10.1093\/annonc\/mdy055","journal-title":"Ann Oncol"},{"issue":"1","key":"4887_CR11","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1007\/s00280-022-04443-1","volume":"90","author":"WW Ma","year":"2022","unstructured":"Ma WW, Li JJ, Azad NS, Lam ET, Diamond JR, Dy GK, Opyrchal M, Zhi J, Kramer D, Chan W-K, Cutler D, Kwan R, Adjei AA, Jimeno A (2022) A phase Ib study of Oraxol (oral paclitaxel and encequidar) in patients with advanced malignancies. Cancer Chemother Pharmacol 90(1):7\u201317. https:\/\/doi.org\/10.1007\/s00280-022-04443-1","journal-title":"Cancer Chemother Pharmacol"},{"issue":"1","key":"4887_CR12","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1200\/jco.21.02953","volume":"41","author":"HS Rugo","year":"2023","unstructured":"Rugo HS, Umanzor GA, Barrios FJ, Vasallo RH, Chivalan MA, Bejarano S, Ram\u00edrez JR, Fein L, Kowalyszyn RD, Kramer ED, Wang H, Kwan MR, Cutler DL (2023) Open-label, randomized, multicenter, phase III Study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol 41(1):65\u201374. https:\/\/doi.org\/10.1200\/jco.21.02953","journal-title":"J Clin Oncol"},{"key":"4887_CR13","unstructured":"US Food & Drug Administration (2022) Assessing the effects of food on drugs in INDs and NDAs \u2013 Clinical pharmacology considerations. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology-considerations. Accessed May 23 2025"},{"issue":"3","key":"4887_CR14","doi-asserted-by":"publisher","first-page":"616","DOI":"10.1007\/s10637-012-9841-7","volume":"31","author":"YS Hong","year":"2013","unstructured":"Hong YS, Kim KP, Lim HS, Bae KS, Ryu MH, Lee JL, Chang HM, Kang YK, Kim H, Kim TW (2013) A phase I study of DHP107, a mucoadhesive lipid form of oral paclitaxel, in patients with advanced solid tumors: crossover comparisons with intravenous paclitaxel. Invest New Drugs 31(3):616\u2013622. https:\/\/doi.org\/10.1007\/s10637-012-9841-7","journal-title":"Invest New Drugs"},{"key":"4887_CR15","doi-asserted-by":"publisher","first-page":"175883592110619","DOI":"10.1177\/17588359211061989","volume":"13","author":"SB Kim","year":"2021","unstructured":"Kim SB, Seo JH, Ahn JH, Kim TY, Kang SY, Sohn J, Yang Y, Park KH, Moon YW, Lim S, Kang MJ, Yoon KE, Cho HJ, Lee KS (2021) Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study). Ther Adv Med Oncol 13:17588359211061989. https:\/\/doi.org\/10.1177\/17588359211061989","journal-title":"Ther Adv Med Oncol"},{"issue":"2","key":"4887_CR16","doi-asserted-by":"publisher","first-page":"402","DOI":"10.1016\/j.clinthera.2014.12.009","volume":"37","author":"H-S Lim","year":"2015","unstructured":"Lim H-S, Bae K-S, Jung J-a, Noh Y-H, Hwang A-K, Jo Y-W, Hong YS, Kim K, Lee J-L, Joon Park S, Kim JE, Kang Y-K, Kim TW (2015) Predicting the efficacy of an oral paclitaxel formulation (DHP107) through modeling and simulation. Clin Ther 37(2):402\u2013417. https:\/\/doi.org\/10.1016\/j.clinthera.2014.12.009","journal-title":"Clin Ther"},{"key":"4887_CR17","unstructured":"US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (2002) Guidance for Industry. Food-effect bioavailability and fed bioequivalence studies. https:\/\/www.fda.gov\/files\/drugs\/published\/Food-Effect-Bioavailability-and-Fed-Bioequivalence-Studies.pdf. Accessed May 23 2025"},{"key":"4887_CR18","doi-asserted-by":"publisher","first-page":"1372","DOI":"10.3389\/fphar.2018.01372","volume":"9","author":"Q Li","year":"2018","unstructured":"Li Q, Zhang H, Zhu X, Liu C, Wu M, Li C, Li X, Gao L, Ding Y (2018) Tolerance, variability and pharmacokinetics of albumin-bound paclitaxel in Chinese breast cancer patients. Front Pharmacol 9:1372. https:\/\/doi.org\/10.3389\/fphar.2018.01372","journal-title":"Front Pharmacol"},{"key":"4887_CR19","doi-asserted-by":"publisher","first-page":"175883591985036","DOI":"10.1177\/1758835919850367","volume":"11","author":"EG Chiorean","year":"2019","unstructured":"Chiorean EG, Cheung WY, Giordano G, Kim G, Al-Batran SE (2019) Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review. Ther Adv Med Oncol 11:1758835919850367. https:\/\/doi.org\/10.1177\/1758835919850367","journal-title":"Ther Adv Med Oncol"},{"issue":"3","key":"4887_CR20","doi-asserted-by":"publisher","first-page":"268","DOI":"10.7150\/jca.12986","volume":"7","author":"HH Loong","year":"2016","unstructured":"Loong HH, Chan AC, Wong AC (2016) Evolving evidence of the efficacy and safety of nab-paclitaxel in the treatment of cancers with squamous histologies. J Cancer 7(3):268\u2013275. https:\/\/doi.org\/10.7150\/jca.12986","journal-title":"J Cancer"},{"issue":"28","key":"4887_CR21","doi-asserted-by":"publisher","first-page":"3325","DOI":"10.1200\/jco.20.01399","volume":"38","author":"CL Loprinzi","year":"2020","unstructured":"Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, Kelley MR, Lavino A, Lustberg MB, Paice JA, Schneider BP, Smith EML, Smith ML, Smith TJ, Wagner-Johnston N, Hershman DL (2020) Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: ASCO guideline update. J Clin Oncol 38(28):3325\u20133348. https:\/\/doi.org\/10.1200\/jco.20.01399","journal-title":"J Clin Oncol"},{"key":"4887_CR22","unstructured":"Pfizer Inc. (2018) TAXOL\u00ae (paclitaxel) INJECTION. Accessed January 22 2026 https:\/\/labeling.pfizer.com\/showlabeling.aspx?format=PDF&id=4559"}],"container-title":["Cancer Chemotherapy and Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00280-026-04887-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00280-026-04887-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00280-026-04887-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T01:02:36Z","timestamp":1780102956000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00280-026-04887-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,30]]},"references-count":22,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["4887"],"URL":"https:\/\/doi.org\/10.1007\/s00280-026-04887-9","relation":{},"ISSN":["1432-0843"],"issn-type":[{"value":"1432-0843","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,30]]},"assertion":[{"value":"26 May 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 March 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 May 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was conducted in accordance with principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol, informed consent forms, and other related documents were reviewed and approved by the competent authority and a central ethics committee.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}},{"value":"All participating patients provided informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}}],"article-number":"59"}}