{"created":"2025-01-14T00:54:30.502263+00:00","id":2011768,"links":{},"metadata":{"_buckets":{"deposit":"3a32b112-e059-4567-a53c-d19c4d3d2454"},"_deposit":{"created_by":7,"id":"2011768","owners":[7],"pid":{"revision_id":0,"type":"depid","value":"2011768"},"status":"published"},"_oai":{"id":"oai:tokushima-u.repo.nii.ac.jp:02011768","sets":["1713853213384:1713853295607"]},"author_link":["1542","798"],"control_number":"2011768","item_10001_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2023-05-30","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"4","bibliographicPageEnd":"507","bibliographicPageStart":"498","bibliographicVolumeNumber":"61","bibliographic_titles":[{"bibliographic_title":"Respiratory Investigation","bibliographic_titleLang":"en"}]}]},"item_10001_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Background: TAS-115, a novel oral multi-kinase inhibitor, showed antifibrotic effects in in vitro and in vivo animal models of idiopathic pulmonary fibrosis (IPF).\nMethods: In this exploratory phase 2 study, IPF patients with a percent predicted forced vital capacity (%FVC) decline ≥5% acquired within the previous 6 months were enrolled. Patients were divided into three pre-treatment cohorts, namely, treatment-naïve, pirfenidone, or nintedanib. TAS-115 was administered orally at 200 mg/day with a 5-day on and 2-day off regimen. After 13 weeks of treatment, patients entered a 13-week extension treatment period where the efficacy was evaluated. The primary endpoint was the difference in slope of %FVC decline at Week 13 from baseline. Safety was also evaluated.\nResults: Between June 2018 and July 2019, 46 patients were enrolled, and 30 (65.2%) patients completed the 13-week treatment. Of these, 22 (47.8%) proceeded to extension treatment. For the primary endpoint, TAS-115 treatment lowered the slope of the %FVC decline of 0.0750%/day (95% confidence interval: 0.0341–0.1158%/day) at Week 13. Efficacy was also demonstrated at Week 26. Treatment-related adverse events were reported in 40 (88.9%) patients, but most were manageable by dose reduction, dose interruption, or symptomatic treatment.\nConclusions: TAS-115 treatment was effective, assessed using intra-patient change in slope of %FVC decline as a surrogate endpoint in patients with IPF pre-treated with pirfenidone or nintedanib and treatment-naïve patients. TAS-115 showed acceptable tolerability and a manageable safety profile.","subitem_description_language":"en","subitem_description_type":"Abstract"}]},"item_10001_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"The Japanese Respiratory Society","subitem_publisher_language":"en"},{"subitem_publisher":"Elsevier","subitem_publisher_language":"en"}]},"item_10001_rights_15":{"attribute_name":"権利情報","attribute_value_mlt":[{"subitem_rights":"This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).","subitem_rights_language":"en"}]},"item_10001_source_id_9":{"attribute_name":"収録物ID","attribute_value_mlt":[{"subitem_source_identifier":"22125345","subitem_source_identifier_type":"ISSN"},{"subitem_source_identifier":"22125353","subitem_source_identifier_type":"ISSN"},{"subitem_source_identifier":"AA12579673","subitem_source_identifier_type":"NCID"},{"subitem_source_identifier":"AA12797947","subitem_source_identifier_type":"NCID"}]},"item_10001_version_type_20":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_1715043197608":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access"}]},"item_1722929371688":{"attribute_name":"出版社版DOI","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_language":"ja","subitem_relation_name_text":"10.1016/j.resinv.2023.04.008"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1016/j.resinv.2023.04.008","subitem_relation_type_select":"DOI"}}]},"item_1723180141928":{"attribute_name":"EID","attribute_value_mlt":[{"subitem_identifier_type":"URI","subitem_identifier_uri":"397853"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorAffiliations":[{"affiliationNameIdentifiers":[{"affiliationNameIdentifierScheme":"ISNI","affiliationNameIdentifierURI":"http://www.isni.org/isni/"}],"affiliationNames":[{"affiliationNameLang":"ja"}]}],"creatorNames":[{"creatorName":"西岡, 安彦","creatorNameLang":"ja"},{"creatorName":"ニシオカ, ヤスヒコ","creatorNameLang":"ja-Kana"},{"creatorName":"Nishioka, 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Arata","creatorNameLang":"en"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_access","date":[{"dateType":"Available","dateValue":"2024-07-11"}],"displaytype":"detail","filename":"resinv_61_4_498.pdf","filesize":[{"value":"884 KB"}],"format":"application/pdf","licensetype":"license_5","mimetype":"application/pdf","url":{"objectType":"fulltext","url":"https://tokushima-u.repo.nii.ac.jp/record/2011768/files/resinv_61_4_498.pdf"},"version_id":"4a354f7b-a272-4162-b103-5c5724863a19"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Clinical trial","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Forced vital capacity","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Idiopathic pulmonary fibrosis","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Multi-kinase inhibitor","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Phase 2","subitem_subject_language":"en","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"Exploratory phase 2 study of the novel oral multi-kinase inhibitor TAS-115 in patients with idiopathic pulmonary fibrosis","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Exploratory phase 2 study of the novel oral multi-kinase inhibitor TAS-115 in patients with idiopathic pulmonary fibrosis","subitem_title_language":"en"}]},"item_type_id":"40001","owner":"7","path":["1713853295607"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2024-07-11"},"publish_date":"2024-07-11","publish_status":"0","recid":"2011768","relation_version_is_last":true,"title":["Exploratory phase 2 study of the novel oral multi-kinase inhibitor TAS-115 in patients with idiopathic pulmonary fibrosis"],"weko_creator_id":"7","weko_shared_id":-1},"updated":"2025-02-03T02:51:46.953046+00:00"}