Phase I study of TAS-121, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with non-small-cell lung ... View Full Text


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Article Info

DATE

2019-02-21

AUTHORS

Makoto Nishio, Haruyasu Murakami, Yuichiro Ohe, Toyoaki Hida, Hiroshi Sakai, Kazuo Kasahara, Fumio Imamura, Tomohisa Baba, Kaoru Kubota, Yukio Hosomi, Tsuneo Shimokawa, Hidetoshi Hayashi, Kazutaka Miyadera, Tomohide Tamura

ABSTRACT

Purpose We investigated the safety, tolerability, pharmacokinetics, and efficacy of TAS-121, a novel, potent, and highly selective third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in Japanese patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC) previously treated with EGFR-TKI. Methods This was an open-label, non-randomized, multi-center, dose escalation, phase I study conducted in three phases (dose escalation, expansion, and extension phases). TAS-121 was administered orally once daily (QD) or twice daily (BID) under fasting conditions in a 21-day treatment cycle. The primary endpoint was dose-limiting toxicities (DLTs) during Cycle 1 of the dose escalation phase. Results In total, 134 patients received treatment. Five and three patients presented a DLT with the QD and BID regimens, respectively. The DLTs were drug-induced liver injury, platelet count decreased, urticaria, interstitial lung disease, and left ventricular failure. The maximum tolerated dose (MTD) was 10 mg/day QD and 8 mg/day BID in the dose escalation phase. The most common adverse drug reactions (ADRs) were dermatological toxicity (89.6%), platelet count decreased (67.2%), and pyrexia (44%) among all patients. Rate of discontinuations due to ADRs at the MTD level were 11.1% with TAS-121 10 mg/day QD and 7.9% with TAS-121 8 mg/day BID. Among 86 T790M-positive patients (confirmed by blood serum sampling in most patients), the objective response rate (ORR) was 28% and highest at 8 mg/day BID (39%). Among 16 T790M-negative patients, the ORR was 19%. Conclusions TAS-121 was well tolerated up to the MTD and demonstrated antitumor activity in Japanese T790M-positive NSCLC patients. Clinical trial registration: JapicCTI-142651. More... »

PAGES

1207-1217

Journal

TITLE

Investigational New Drugs

ISSUE

6

VOLUME

37

Author Affiliations

  • Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550 Japan
  • Division of Thoracic Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka, 411-8777 Japan
  • Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
  • Department of Thoracic Oncology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya City, Aichi 464-8681 Japan
  • Department of Thoracic Oncology, Saitama Cancer Center, 780 Komuro, Inamachi, Kitaadachigun, Saitama, 362-0806 Japan
  • Department of Respiratory Medicine, Kanazawa University Graduate School of Medicine, 13-1 Takaramachi, Kanazawa City, Ishikawa 920-8641 Japan
  • Department of Thoracic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka City, Osaka, 541-8567 Japan
  • Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama City, Kanagawa 236-0051 Japan
  • Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, 113-8603 Japan
  • Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-Ku, Tokyo, 113-8677 Japan
  • Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen’s Hospital, 56 Okazawacho, Hodogaya-ku, Yokohama City, Kanagawa 240-8555 Japan
  • Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Onohigashi, Osakasayama City, Osaka 589-8511 Japan
  • Drug Discovery & Development I, Taiho Pharmaceutical Co., Ltd, 3 Okubo, Tsukuba, Ibaraki, 300-2611 Japan
  • Thoracic Center, St. Luke’s International Hospital, 9-1 Akashicho, Chuo-ku, Tokyo, 104-0045 Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10637-019-00732-4

    DOI

    http://dx.doi.org/10.1007/s10637-019-00732-4

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1112283090

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30790152


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        "description": "Purpose We investigated the safety, tolerability, pharmacokinetics, and efficacy of TAS-121, a novel, potent, and highly selective third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in Japanese patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC) previously treated with EGFR-TKI. Methods This was an open-label, non-randomized, multi-center, dose escalation, phase I study conducted in three phases (dose escalation, expansion, and extension phases). TAS-121 was administered orally once daily (QD) or twice daily (BID) under fasting conditions in a 21-day treatment cycle. The primary endpoint was dose-limiting toxicities (DLTs) during Cycle 1 of the dose escalation phase. Results In total, 134 patients received treatment. Five and three patients presented a DLT with the QD and BID regimens, respectively. The DLTs were drug-induced liver injury, platelet count decreased, urticaria, interstitial lung disease, and left ventricular failure. The maximum tolerated dose (MTD) was 10\u00a0mg/day QD and 8\u00a0mg/day BID in the dose escalation phase. The most common adverse drug reactions (ADRs) were dermatological toxicity (89.6%), platelet count decreased (67.2%), and pyrexia (44%) among all patients. Rate of discontinuations due to ADRs at the MTD level were 11.1% with TAS-121 10\u00a0mg/day QD and 7.9% with TAS-121 8\u00a0mg/day BID. Among 86\u00a0T790M-positive patients (confirmed by blood serum sampling in most patients), the objective response rate (ORR) was 28% and highest at 8\u00a0mg/day BID (39%). Among 16\u00a0T790M-negative patients, the ORR was 19%. Conclusions TAS-121 was well tolerated up to the MTD and demonstrated antitumor activity in Japanese T790M-positive NSCLC patients. Clinical trial registration: JapicCTI-142651.", 
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    24 schema:description Purpose We investigated the safety, tolerability, pharmacokinetics, and efficacy of TAS-121, a novel, potent, and highly selective third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in Japanese patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC) previously treated with EGFR-TKI. Methods This was an open-label, non-randomized, multi-center, dose escalation, phase I study conducted in three phases (dose escalation, expansion, and extension phases). TAS-121 was administered orally once daily (QD) or twice daily (BID) under fasting conditions in a 21-day treatment cycle. The primary endpoint was dose-limiting toxicities (DLTs) during Cycle 1 of the dose escalation phase. Results In total, 134 patients received treatment. Five and three patients presented a DLT with the QD and BID regimens, respectively. The DLTs were drug-induced liver injury, platelet count decreased, urticaria, interstitial lung disease, and left ventricular failure. The maximum tolerated dose (MTD) was 10 mg/day QD and 8 mg/day BID in the dose escalation phase. The most common adverse drug reactions (ADRs) were dermatological toxicity (89.6%), platelet count decreased (67.2%), and pyrexia (44%) among all patients. Rate of discontinuations due to ADRs at the MTD level were 11.1% with TAS-121 10 mg/day QD and 7.9% with TAS-121 8 mg/day BID. Among 86 T790M-positive patients (confirmed by blood serum sampling in most patients), the objective response rate (ORR) was 28% and highest at 8 mg/day BID (39%). Among 16 T790M-negative patients, the ORR was 19%. Conclusions TAS-121 was well tolerated up to the MTD and demonstrated antitumor activity in Japanese T790M-positive NSCLC patients. Clinical trial registration: JapicCTI-142651.
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    347 grid-institutes:grid.9707.9 schema:alternateName Department of Respiratory Medicine, Kanazawa University Graduate School of Medicine, 13-1 Takaramachi, Kanazawa City, Ishikawa 920-8641 Japan
    348 schema:name Department of Respiratory Medicine, Kanazawa University Graduate School of Medicine, 13-1 Takaramachi, Kanazawa City, Ishikawa 920-8641 Japan
    349 rdf:type schema:Organization
     




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