NCT01910025已完成2 期
Phase 2 Study of ADI PEG 20 in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy
Polaris Group5 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年12月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Response Rate
研究概览
简要总结
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that have arginine. In this study, the primary efficacy variable will be assessment of tumor response rate.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ADI-PEG 20
Experimental
arginine deiminase formulated with polyethlene glycol
干预措施: ADI-PEG 20 (Drug)
结局指标
主要结局
Response Rate
时间窗: 2 years estimated
Determined by response criteria for cutaneous and non-cutaneous malignant lymphoma
次要结局
- Safety and Tolerability(2 years estimated)
研究者
研究点 (5)
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