Okusaka, Takuji http://orcid.org/0000-0003-1729-807X
Morimoto, Manabu
Eguchi, Yuichiro
Nakamura, Shinichiro
Iino, Shuichi
Kageyama, Rie
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Napabucasin Combined with Sorafenib in Japanese Patients with Unresectable Hepatocellular Carcinoma
https://doi.org/10.1007/s40268-023-00416-8
Funding for this research was provided by:
Sumitomo Pharma
Article History
Accepted: 26 February 2023
First Online: 15 May 2023
Declarations
:
: This study was supported by research funding from Sumitomo Pharma Co., Ltd. Development of napabucasin by Sumitomo Pharma Co., Ltd has now been suspended.
: Takuji Okusaka has received grants and personal fees from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd, Sumitomo Dainippon Pharma Co., Ltd, Eisai Co., Ltd and Incyte Biosciences Japan GK; received grants from EP-CRSU Co., Ltd, Linical Co., Ltd, MSD K.K., and Syneos Healthfrom; and received personal fees from Bristol-Myers Squibb Company, Daiichi Sankyo Co., Ltd, Eli Lilly Japan K.K., Fujifilm Toyama Chemical Co., Ltd, Johnson & Johnson K.K., Mundipharma K.K., Nihon Servier Co., Ltd, Nippon Shinyaku Co., Ltd, Ono Pharmaceutical Co., Ltd, Pfizer Japan Inc., Taiho Pharmaceutical Co. Ltd, Teijin Pharma Ltd, and Yakult Honsha Co., Ltd. Shuichi Iino and Rie Kageyama are employees of Sumitomo Pharma Co., Ltd. Manabu Morimoto, Yuichiro Eguchi, and Shinichiro Nakamura have no conflicts of interest to declare.
: This study was conducted in accordance with Good Clinical Practice ordinance, the ethical principles that have their origins in the Declaration of Helsinki, and all relevant national and international regulatory requirements. The protocol and all other study documentation were approved by the Institutional Review Board of each study center before enrollment of any patients into the study.
: All patients provided written informed consent for study participation.
: Not applicable.
: The research data underlying this study are subject to restrictions and cannot be shared.
: Takuji Okusaka, Manabu Morimoto, Yuichiro Eguchi, Shinichiro Nakamura, Shuichi Iino, and Rie Kageyama contributed to the study design and conduct, and to data collection. Data analysis was performed by Shuichi Iino and Rie Kageyama, and all authors contributed to data interpretation. All authors substantively reviewed each manuscript draft and approved the final version.
: Not applicable.