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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.

Official Title
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A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

Conditions
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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: Patients aged 20 years or older at the submission of the written informed consent form Patients that have undergone therapy after at least 2 prior systemic therapies (anti-CD20 Ab, chemo, and so on) for relapsed or refractory B-cell NHL Patients who have not undergone phosphatidylinositol 3-kinase (PI3K) inhibitors to date Patients who have not undergone Bruton's tyrosine kinase (BTK) inhibitors to date Patients with Eastern Cooperative Oncology Group Performance status (ECOG PS) 0 or 1 Exclusion Criteria: Patients with relapsed or refractory B-cell NHL who is categorized into Small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), Lymphoplasmacytic lymphoma (LPL) by WHO classification Patients who have been histologically confirmed FL Grade 3b transformation from Follicular lymphoma (FL) to an aggressive lymphoma at least once Patients with lymphomatous involvement of the central nervous system Patients with uncontrolled clinically significant illness Patients with active interstitial lung disease or a history thereof

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> | Drug: ME-401<br>* In the first 2 cycles (1 cycle is 28 days), subjects will be administered 60 mg of ME-401 orally once a day on a continuous schedule (CS). After that, subjects will be administered 60 mg of ME-401 orally once a day for the first 7 days, followed by rest for 21 days on an intermittent schedule (IS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is measured as the proportion of subjects achieving the best response rating of complete response (CR) or partial response (PR) prior to first progressive disease (PD). | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ME-401 as assessed by the duration of response (DOR) |  | Up to approximately 4 years | 
| Efficacy of ME-401 as assessed by the progression-free survival (PFS) |  | Up to approximately 4 years | 
| Efficacy of ME-401 as assessed by CR |  | Up to approximately 4 years | 
| Efficacy of ME-401 as assessed by the Time to treatment failure (TTF) |  | Up to approximately 4 years | 
| Efficacy of ME-401 as assessed by the objective response rate (ORR) |  | Up to approximately 4 years | 
| Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs) |  | Up to approximately 4 years | 
| Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI) |  | Up to approximately 4 years | 
| Plasma concentration level of ME-401 |  | Up to approximately 4 years |