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

Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Active, not recruiting ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Actual Enrollment :
9 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Actual Study Start Date :
Apr 29, 2019
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ME-401

ME-401 administered orally

Drug: ME-401
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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-emergent adverse events (TEAEs) [Up to approximately 1 year]

Secondary Outcome Measures

  1. Plasma concentration level of ME-401 [Up to approximately 2 years]

  2. Maximum plasma drug concentration (Cmax) [Up to approximately 2 years]

  3. Area under the plasma drug concentration time curve (AUC) [Up to approximately 2 years]

  4. Terminal half-life (t1/2) [Up to approximately 2 years]

  5. Efficacy of ME-401 as assessed by the objective response rate (ORR) [Up to approximately 2 years]

  6. Efficacy of ME-401 will be assessed by the duration of response (DOR) [Up to approximately 2 years]

  7. Efficacy of ME-401 will be assessed by the progression-free survival (PFS) [Up to approximately 2 years]

  8. Efficacy of ME-401 will be assessed by the time to response (TTR) [Up to approximately 2 years]

Eligibility Criteria


Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • 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:
  • 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.

Contacts and Locations


Site City State Country Postal Code
1 National Hospital Organization Nagoya Medical Center Nagoya Aichi Japan 460-0001
2 Hokkaido University Hospital Sapporo Hokkaido Japan 060-0814
3 National Cancer Center Hospital Chuo-ku Tokyo Japan 104-0045
4 The Cancer Institute Hospital of JFCR Koto-ku Tokyo Japan 135-8550
5 Kyushu University Hospital Fukuoka Japan 812-8582
6 Okayama University Hospital Okayama Japan 700-8558

Sponsors and Collaborators

  • Kyowa Kirin Co., Ltd.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Kyowa Kirin Co., Ltd. Identifier:
Other Study ID Numbers:
  • ME-401-K01
First Posted:
Jun 13, 2019
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2021