Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

April 29, 2019

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions
Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Interventions
DRUG

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."

Trial Locations (9)

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

466-8650

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya

060-0814

Hokkaido University Hospital, Sapporo

113-8677

Tokyo Metropolitan Komagome Hospital, Bunkyo-ku

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

The Cancer Institute Hospital of JFCR, Koto-ku

030-8553

Aomori Prefectural Central Hospital, Aomori

812-8582

Kyushu University Hospital, Fukuoka

700-8558

Okayama University Hospital, Okayama

All Listed Sponsors
lead

Kyowa Kirin Co., Ltd.

INDUSTRY