A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 17
- 主要终点
- Body weight; Lean body mass; Functional performance
研究概览
简要总结
Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.
详细描述
Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.
- •Involuntary loss of body weight greater than 5% within the past 6 months
排除标准
- •Presently hospitalized or in a nursing care facility.
- •Inability to increase food intake from secondary causes.
- •Liver disease
- •If female-pregnant, breast-feeding or of childbearing potential.
研究组 & 干预措施
3
RC-1291 100mg
干预措施: RC-1291 (Drug)
2
RC-1291 50mg
干预措施: RC-1291 (Drug)
1
干预措施: placebo (Drug)
结局指标
主要结局
Body weight; Lean body mass; Functional performance
时间窗: 4 weeks
次要结局
未报告次要终点