A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 31
- 主要终点
- Hand grip strength and body weight
研究概览
简要总结
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
详细描述
Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage IIIB or IV NSCLC
- •eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab
排除标准
- •mixed large and small cell histologies for lung cancer
- •significant obesity, BMI > 30
研究组 & 干预措施
1 Active 50 mg
干预措施: anamorelin HCl (Drug)
2 Active 100 mg
干预措施: anamorelin HCl (Drug)
3 Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Hand grip strength and body weight
时间窗: Twelve weeks
次要结局
- Quality of Life and Biomarker(Twelve weeks)