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

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03985189

Collaborator

(none)

Enrollment

Locations

Arm

65.1

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

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
Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma	Drug: ME-401	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

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

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.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03985189

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:

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Study Results

No Results Posted as of Dec 28, 2021