NCT00895726已完成2 期
Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Muscle size and function
研究概览
简要总结
Primary Objective:
To assess the efficacy of APD209 in adult patients with active cachexia associated with advanced malignancy and not caused by simple starvation.
Secondary Objective:
To assess the safety of APD209 in patients with advanced malignancy and active cachexia.
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
- •Involuntary loss of weight of >= 2% in 2 months or >= 5% in 6 months, and ongoing in recent weeks, without (or with successfully treated) secondary causes of impaired oral nutritional intake (simple starvation).
排除标准
- 未提供
研究组 & 干预措施
APD209
Experimental
干预措施: APD209 (Drug)
结局指标
主要结局
Muscle size and function
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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