The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
\[Phase 1 study (DLT evaluation)\] 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, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Tokyo Metropolitan Komagome Hospital
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 1 year
[Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS)
Time frame: Up to approximately 2 years
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR)
Time frame: Up to approximately 2 years
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Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Aomori Prefectural Central Hospital
Aomori, Japan
Kyushu University Hospital
Fukuoka, Japan
Okayama University Hospital
Okayama, Japan