NCT03985189已完成1 期
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
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 9
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[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.
排除标准
- •[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.
研究组 & 干预措施
ME-401
Experimental
ME-401 administered orally
干预措施: ME-401 (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to approximately 1 year
次要结局
- [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)
研究者
研究点 (9)
Loading locations...
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