14
Participants
Start Date
April 29, 2019
Primary Completion Date
May 31, 2028
Study Completion Date
May 31, 2028
ME-401
"\[Phase 1 study (DLT evaluation)\] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability.~\[Roll over study\] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met."
National Hospital Organization Nagoya Medical Center, Nagoya
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya
Hokkaido University Hospital, Sapporo
Tokyo Metropolitan Komagome Hospital, Bunkyo-ku
National Cancer Center Hospital, Chuo-ku
The Cancer Institute Hospital of JFCR, Koto-ku
Aomori Prefectural Central Hospital, Aomori
Kyushu University Hospital, Fukuoka
Okayama University Hospital, Okayama
Kyowa Kirin Co., Ltd.
INDUSTRY