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

Primary Purpose

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

Status
Active
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ME-401
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Hospital Organization Nagoya Medical Center
  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
  • Hokkaido University Hospital
  • Tokyo Metropolitan Komagome Hospital
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Aomori Prefectural Central Hospital
  • Kyushu University Hospital
  • Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ME-401

Arm Description

ME-401 administered orally

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2019
Last Updated
April 11, 2023
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03985189
Brief Title
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ME-401
Arm Type
Experimental
Arm Description
ME-401 administered orally
Intervention Type
Drug
Intervention Name(s)
ME-401
Intervention Description
[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.
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame
Up to approximately 1 year
Secondary Outcome Measure Information:
Title
[Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401
Time Frame
Up to approximately 2 years
Title
[Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)
Time Frame
Up to approximately 2 years
Title
[Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)
Time Frame
Up to approximately 2 years
Title
[Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)
Time Frame
Up to approximately 2 years
Title
[Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time Frame
Up to approximately 2 years
Title
[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
Title
[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
Title
[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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0814
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36107394
Citation
Goto H, Izutsu K, Ennishi D, Mishima Y, Makita S, Kato K, Hanaya M, Hirano S, Narushima K, Teshima T, Nagai H, Ishizawa K. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921. doi: 10.1007/s12185-022-03450-5. Epub 2022 Sep 15.
Results Reference
derived
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/36107394/
Description
Goto H, Izutsu K, Ennishi D, et al. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921.

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

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