Mizugaki, Hidenori
Yamamoto, Noboru http://orcid.org/0000-0002-0787-2851
Murakami, Haruyasu
Kenmotsu, Hirotsugu
Fujiwara, Yutaka
Ishida, Yoshimasa
Kawakami, Tomohisa
Takahashi, Toshiaki
Funding for this research was provided by:
Chugai Pharmaceutical Co., LTD
Article History
Received: 20 April 2016
Accepted: 22 June 2016
First Online: 1 July 2016
Compliance with ethical standards
:
: Hidenori Mizugaki has nothing to disclose.Noboru Yamamoto reports grants from Chugai, grants from Eli Lilly, grants from Taiho, grants from Eisai, grants from Quintiles, grants from Astellas, grants from BMS, grants from Novartis, grants from Daiichi-Sankyo, grants from Pfizer, grants from Boehringer Ingelheim, grants from Kyowa-Hakko Kirin, grants from Bayer, outside the submitted work.Haruyasu Murakami reports personal fees from Chugai, outside the submitted work;Hirotsugu Kenmotsu reports personal fees from Chugai Pharmaceutical Co, Ltd., outside the submitted work.Yutaka Fujiwara reports grants from AstraZeneca, grants from Eli Lilly, grants from Eisai, grants from MerckSerono, grants from Chugai, grants from GlaxoSmithKline, outside the submitted work.Yoshimasa Ishida is a full time employee of Chugai Pharmaceutical.Tomohisa Kawakami is a full time employee of Chugai Pharmaceutical.Toshiaki Takahashi reports grants and personal fees from AstraZeneca K.K., grants and personal fees from Eli Lilly Japan K.K., grants and personal fees from Chugai Pharmaceutical Co., Ltd., grants and personal fees from Ono Pharmaceutical Co., Ltd., personal fees from Boehringer Ingelheim Japan, INC, outside the submitted work.
: Written informed consent was obtained from all patients. This study was approved by the institutional review board at the National Cancer Center and Shizuoka Cancer Center and was conducted in accordance with Japanese Good Clinical Practice (GCP) guidelines.The study was conducted in compliance with the Declaration of Helsinki, the study protocol, the standards stipulated in Paragraph 3 of Article 14 and Article 80–2 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (Pharmaceuticals and Medical Devices Act), and the Ministerial Ordinance on Good Clinical Practice for Drugs (GCP).