Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
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|
Arms and Interventions
ME-401 administered orally
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.
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]
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.
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
|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.
Study Documents (Full-Text)None provided.