Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
- Conditions
- Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT03985189
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 14
[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.
[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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ME-401 ME-401 ME-401 administered orally
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) Up to approximately 1 year
- Secondary Outcome Measures
Name Time Method [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR) Up to approximately 2 years [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401 Up to approximately 2 years
Related Research Topics
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Trial Locations
- Locations (9)
The Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
Aomori Prefectural Central Hospital
🇯🇵Aomori, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
🇯🇵Nagoya, Aichi, Japan
Okayama University Hospital
🇯🇵Okayama, Japan