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出境医 / 临床实验 / Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

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

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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 : April 29, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021
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) [ Time Frame: Up to approximately 1 year ]

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

  • 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
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Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date December 10, 2019
Actual Study Start Date  ICMJE April 29, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019) 		Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Plasma concentration level of ME-401 [ Time Frame: Up to approximately 2 years ]
  • Maximum plasma drug concentration (Cmax) [ Time Frame: Up to approximately 2 years ]
  • Area under the plasma drug concentration time curve (AUC) [ Time Frame: Up to approximately 2 years ]
  • Terminal half-life (t1/2) [ Time Frame: Up to approximately 2 years ]
  • Efficacy of ME-401 as assessed by the objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]
  • Efficacy of ME-401 will be assessed by the duration of response (DOR) [ Time Frame: Up to approximately 2 years ]
  • Efficacy of ME-401 will be assessed by the progression-free survival (PFS) [ Time Frame: Up to approximately 2 years ]
  • Efficacy of ME-401 will be assessed by the time to response (TTR) [ Time Frame: Up to approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Official Title  ICMJE A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: ME-401
ME-401 administered orally
Intervention: Drug: ME-401
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019) 		12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985189
Other Study ID Numbers  ICMJE ME-401-K01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kyowa Kirin Co., Ltd.
Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin Co., Ltd.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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