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• W2801963883 abstract "// Yutaka Fujiwara 1 , Masayuki Takeda 2 , Noboru Yamamoto 1 , Kazuhiko Nakagawa 2 , Kaname Nosaki 3 , Ryo Toyozawa 3 , Chihiro Abe 4 , Ryota Shiga 4 , Kenji Nakamaru 4 and Takashi Seto 3 1 Department of Experimental Therapeutics, National Cancer Center Hospital, Chuo-ku, Tokyo 104-0045, Japan 2 Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama-shi, Osaka 589-8511, Japan 3 Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Minami-ku, Fukuoka-shi, Fukuoka 811-1395, Japan 4 Daiichi Sankyo Co., Ltd., Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan Correspondence to: Yutaka Fujiwara, email: yutakafu@ncc.go.jp Keywords: DS-6051b; non-small cell lung cancer; ROS1; pharmacokinetics; Japanese Received: December 19, 2017      Accepted: April 06, 2018      Published: May 04, 2018 ABSTRACT Oncogenic ROS1 and NTRK fusions were reported in solid tumors, including non-small cell lung cancer (NSCLC). DS-6051b is an oral, potent selective small molecule tyrosine kinase inhibitor. We report the safety, tolerability, efficacy, and pharmacokinetics of DS-6051b in 15 Japanese patients with NSCLC harboring ROS1 fusions. Patients received DS-6051b once daily (400 mg n = 6; 600 mg n = 6; or 800 mg n = 3) for cycles of 3 weeks. Safety, tolerability, maximum-tolerated dose, pharmacokinetics, and recommended dose for phase II were determined. Common treatment-related adverse events were increased: aspartate aminotransferase and alanine aminotransferase (80.0% each), diarrhea (53.3%), and nausea (46.7%). Dose-limiting toxicities (two grade-3 alanine aminotransferase increases) were seen in the 800 mg cohort. The maximum-tolerated dose and recommended phase II dose was 600 mg once daily. Plasma concentrations of free DS-6051b and DS-6051a increased with dose. Compared with a US phase I study, AUC 0–24 h on day 15 was higher but narrowed after body weight correction. Objective response rate was 58.3% in patients with target lesions ( n = 12) and 66.7% in crizotinib-naïve patients ( n = 9). Disease control rate was 100%. DS-6051b is well tolerated and effective in Japanese patients with NSCLC harboring ROS1 fusions and might be a targeted therapy for advanced NSCLC." @default.
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• W2801963883 date "2018-05-04" @default.
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• W2801963883 title "Safety and pharmacokinetics of DS-6051b in Japanese patients with non-small cell lung cancer harboring <i>ROS1</i> fusions: a phase I study" @default.
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• W2801963883 doi "https://doi.org/10.18632/oncotarget.25263" @default.
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