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

Study Overview
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Brief Summary
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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

Official Title
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A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study

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

Intervention / Treatment
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* Drug: ME-401


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [Phase 1 study (DLT evaluation)] Patients aged 20 years or older at the submission of the written informed consent form Patients with relapsed or refractory B-cell NHL Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date. Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors. Patients with ECOG PS 0 or 1. Exclusion Criteria: [Phase 1 study (DLT evaluation)] Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product. Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those. Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test. Patients with active interstitial lung disease or a history thereof. Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ME-401<br>ME-401 administered orally | Drug: ME-401<br>* [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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events (TEAEs) |  | Up to approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401 |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax) |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC) |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2) |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR) |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR) |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS) |  | Up to approximately 2 years | 
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR) |  | Up to approximately 2 years |