A phase II study of ME2136 (Asenapine Maleate) plus standard antiemetic therapy for patients, including diabetic patients, receiving cisplatin-based chemotherapy

Ethics approval

This study was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice Guideline. It was reviewed and approved by the Certified Review Board of the Shizuoka Cancer Center(30 October 2020 / 2020–17-2020–1-6).

Consent to participate

All enrolled patients provided their informed consent.

Consent to publish

Not applicable.

Competing interests

Satoshi Hamauchi reports lecture fees from Ono Pharmaceutical Co., Ltd. Tomoya Yokota reports advisor to Merck Biopharma, MSD, Rakuten Medical, and Astellas Pharma and lecture fees from Merck Biopharma, Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, AstraZeneca, Chugai Pharmaceutical Co., Ltd., MSD, Eli Lilly Japan, and Eisai. Takahiro Tsushima reports lecture fees from Taiho Pharmaceutical Co., Ltd., Ono pharmaceutical Co., Ltd., Bristol Meyers Squibb Co., and MSD. Kunihiro Fushiki reports lecture fees from Ono pharmaceutical Co., Ltd., Bristol-Meyers Squibb Co., and MSD. Tateaki Naito reports grants from Kracie Holdings and lecture fees from Ono Pharmaceutical Co., Ltd. outside the submitted work. Akira Ono reports lecture fees from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., BMS, and Indica labs; research grants to institution from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., and Janssen Pharmaceutical K.K. Yusuke Onozawa reports lecture fees from Novartis. Haruyasu Murakami reports grants and lecture fees from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo, and Taiho Pharmaceutical Co., Ltd., grants from AbbVie, IQvia, and Bayer, lecture fees from Takeda, Amgen, Bristol-Myers Squibb, MSD, Pfizer, Novartis, Eli Lilly Japan, Eisai, and Nihonkayaku, advisory to Chugai Pharmaceutical Co., Ltd., GAIA BioMedicine, Daiichi Sankyo, Takeda, and Kyowa Kirin. Kentaro Yamazaki reports research funding from Esai., Pfizer., and Ono Pharmaceutical Co., Ltd., and lecture fees from Chugai Pharmaceutical Co., Ltd., Takeda, Eli Lilly Japan, Taiho Pharmaceutical Co., Ltd., Merck biopharma, Yakult, Ono pharmaceutical Co., Ltd., Bristol-Myers Squibb. Toshiaki Takahashi reports grants from AstraZeneca K.K., Chugai Pharma Co., Ltd., Eli Lilly Japan, Ono Pharmaceutical Co., Ltd., MSD, Pfizer, AMGEN, Boehringer Ingelheim, Merck Biopharma, personal fees from AstraZeneca K.K., Chugai Pharma Co., Ltd., Eli Lilly Japan, Ono Pharmaceutica Co., Ltd., MSD, Pfizer, Boehringer Ingelheim, Roche Diagnostics, Takeda, and Yakult, outside the submitted work. Yasuyuki Hirashima reports grants from AstraZeneca K.K., Ezai, Merck Biopharma, and MSD, lecture fees from AstraZeneca K.K., Chugai Pharma Co., Ltd., and Takeda outside the submitted work. Keita Mori reports lecture fees from Ono Pharmaceutical Co., Ltd. outside the submitted work.

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