First-in-Human Phase I Study of an Oral HSP90 Inhibitor, TAS-116, in Patients with Advanced Solid Tumors.


Journal

Molecular cancer therapeutics
ISSN: 1538-8514
Titre abrégé: Mol Cancer Ther
Pays: United States
ID NLM: 101132535

Informations de publication

Date de publication:
03 2019
Historique:
received: 25 07 2018
revised: 24 10 2018
accepted: 11 01 2019
pubmed: 27 1 2019
medline: 13 3 2020
entrez: 26 1 2019
Statut: ppublish

Résumé

HSP90 is involved in stability and function of cancer-related proteins. This study was conducted to define the MTD, safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of TAS-116, a novel class, orally available, highly selective inhibitor of HSP90. Patients with advanced solid tumors received TAS-116 orally once daily (QD, step 1) or every other day (QOD, step 2) in 21-day cycles. Each step comprised a dose escalation phase to determine MTD and an expansion phase at the MTD. In the dose escalation phase, an accelerated dose-titration design and a "3+3" design were used. Sixty-one patients were enrolled in Japan and the United Kingdom. MTD was determined to be 107.5 mg/m

Identifiants

pubmed: 30679388
pii: 1535-7163.MCT-18-0831
doi: 10.1158/1535-7163.MCT-18-0831
doi:

Substances chimiques

Benzamides 0
HSP90 Heat-Shock Proteins 0
Protein Kinase Inhibitors 0
Pyrazoles 0
TAS-116 0

Types de publication

Clinical Trial, Phase I Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

531-540

Subventions

Organisme : Cancer Research UK
ID : 11566
Pays : United Kingdom
Organisme : Department of Health
ID : RP-2016-07-028
Pays : United Kingdom

Informations de copyright

©2019 American Association for Cancer Research.

Auteurs

Akihiko Shimomura (A)

Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.

Noboru Yamamoto (N)

Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan. nbryamam@ncc.go.jp.
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Shunsuke Kondo (S)

Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.

Yutaka Fujiwara (Y)

Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Shigenobu Suzuki (S)

Department of Ophthalmic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Noriko Yanagitani (N)

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Atsushi Horiike (A)

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Satoru Kitazono (S)

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Fumiyoshi Ohyanagi (F)

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Toshihiko Doi (T)

Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Department of Experimental Therapeutics, National Cancer Center Hospital East, Chiba, Japan.

Yasutoshi Kuboki (Y)

Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.

Akihito Kawazoe (A)

Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.

Kohei Shitara (K)

Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.

Izumi Ohno (I)

Department of Hepatobiliary Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.

Udai Banerji (U)

Clinical Pharmacology and Trials, The Institute of Cancer Research and The Royal Marsden, London, United Kingdom.

Raghav Sundar (R)

Department of Haematology-Oncology, The Institute of Cancer Research and The Royal Marsden, London, United Kingdom.
National University Health System, Singapore.

Shuichi Ohkubo (S)

Discovery and Preclinical Research Division, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.

Elizabeth M Calleja (EM)

Taiho Oncology, Inc., Princeton, New Jersey.

Makoto Nishio (M)

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

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Classifications MeSH