An Open-Label, Single-Arm, Multicenter Phase 1 Study Evaluating the Safety and Pharmacokinetics of Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Duvelisib
研究概览
简要总结
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lymphoma (excluding lymphoblastic lymphoma)
- •Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2
- •Life expectancy of at least 3 months
排除标准
- •Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
- •Ongoing treatment with chronic immune-suppressants
- •Overt CNS lymphoma
- •Inadequate hepatic, bone marrow, or renal function
- •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
- •Venous thromboembolic event requiring anticoagulation
- •Presence of active systemic infection within 72 hours of treatment
- •Human immunodeficiency virus (HIV) infection
- •Pregnant or lactating women
研究组 & 干预措施
duvelisib
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
干预措施: duvelisib (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Duvelisib
时间窗: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Number of participants reporting Treatment-emergent Adverse Events
时间窗: Throughout the study for approximately 2 years
The number of participants reporting treatment-emergent adverse events.
Time to Maximum Observed Concentration (Tmax) of Duvelisib
时间窗: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
时间窗: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
次要结局
- Progression Free Survival(Throughout the study for approximately 2 years)
- Overall Survival(Throughout the study for approximately 2 years)
- Overall Response Rate(Throughout the study for approximately 2 years)