| Item type |
文献 / Documents(1) |
| 公開日 |
2024-07-11 |
| アクセス権 |
|
|
アクセス権 |
open access |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
|
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.1016/j.resinv.2023.04.008 |
|
|
言語 |
ja |
|
|
関連名称 |
10.1016/j.resinv.2023.04.008 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
Exploratory phase 2 study of the novel oral multi-kinase inhibitor TAS-115 in patients with idiopathic pulmonary fibrosis |
|
言語 |
en |
| 著者 |
西岡, 安彦
ホンマ, サカエ
オグラ, タカシ
佐藤, 正大
アライ, ナオキ
トミイ, ケイスケ
カミオ, コウイチロウ
サカモト, ススム
ミヤザキ, ヤスナリ
トミオカ, ヒロミ
ヒサタ, シュウ
ハンダ, トモヒロ
アズマ, アラタ
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
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).
Methods: 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.
Results: 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.
Conclusions: 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. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Clinical trial |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Forced vital capacity |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Idiopathic pulmonary fibrosis |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Multi-kinase inhibitor |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Phase 2 |
| 書誌情報 |
en : Respiratory Investigation
巻 61,
号 4,
p. 498-507,
発行日 2023-05-30
|
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
22125345 |
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
22125353 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA12579673 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA12797947 |
| 出版者 |
|
|
出版者 |
The Japanese Respiratory Society |
|
言語 |
en |
| 出版者 |
|
|
出版者 |
Elsevier |
|
言語 |
en |
| 権利情報 |
|
|
言語 |
en |
|
権利情報 |
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
| EID |
|
|
識別子 |
397853 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
resinv_61_4_498.pdf (884 KB)
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