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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03985189
Recruitment Status : Active, not recruiting
First Posted : June 13, 2019
Last Update Posted : April 13, 2023
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma Drug: ME-401 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 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 and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: ME-401
ME-401 administered orally
 Drug: ME-401

[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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 1 year ]

Secondary Outcome Measures :
  1. [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401 [ Time Frame: Up to approximately 2 years ]
  2. [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax) [ Time Frame: Up to approximately 2 years ]
  3. [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC) [ Time Frame: Up to approximately 2 years ]
  4. [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2) [ Time Frame: Up to approximately 2 years ]
  5. [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]
  6. [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 ]
  7. [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 ]
  8. [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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985189


Locations
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Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi, Japan, 466-8650
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-0814
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Aomori Prefectural Central Hospital
Aomori, Japan, 030-8553
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Okayama University Hospital
Okayama, Japan, 700-8558
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT03985189    
Other Study ID Numbers: ME-401-K01
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: April 13, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases