A Phase II, Open-Label, Single-Arm Study to Investigate the Safety, Tolerability, and Anti-tumor Activity of AZD4205 Treating Relapsed or Refractory Peripheral T Cell Lymphoma (r/r PTCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 19
- 主要终点
- Objective response rate (ORR) assessed by investigators per Lugano criteria
研究概览
简要总结
This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AZD4205 treatment
Cohort 1: Newly enrolled participants with r/r PTCL who were never exposed to AZD4205 (receive 150 mg or 75 mg). Cohort 2: Participants from other completed AZD4205 study if they are still benefiting from AZD4205 (receive 150 mg).
干预措施: AZD4205 (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by investigators per Lugano criteria
时间窗: Up to 2 years
To assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL.
次要结局
- Duration of Response (DoR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)
- Adverse events graded by CTCAE version 5.0(Up to 2 years)
- Plasma concentration of AZD4205(Up to 2 years)
- Progression-free Survival (PFS)(Up to 2 years)