NCT01435863已完成1 期
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Incidence of dose-limiting toxicity and adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent
- •Patients with histologically confirmed diagnosis of the following:
- •Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
- •Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
- •Angioimmunoblastic T-cell Lymphoma (AITL)
- •Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
- •Have at least 1 evaluable lesion
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Life expectancy of at least 3 months
排除标准
- 未提供
研究组 & 干预措施
SP-02L
Experimental
干预措施: SP-02L (darinaparsin for injection) (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity and adverse events
时间窗: 12 or 16 weeks
次要结局
- Tumor response (overall response)(2 and 4 cycles)
- Plasma concentration-time profile(0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15)
研究者
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