A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 124
- 试验地点
- 83
- 主要终点
- Change in Safety parameters.
研究概览
简要总结
The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).
详细描述
This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia.
It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio.
A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24.
Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1.
Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of NSCLC incurable by other treatments including surgery
- •A ≥5 % loss of body weight in the preceding 3 months
- •A C-reactive protein (CRP) concentration ≥ 10 mg/L
- •Life Expectancy of at least 12 weeks
排除标准
- •Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
- •AST/ALT ≥ 3 x ULN at screening
- •Hemoglobin < 8 g/dL at Screening
- •History of or active diagnosis of Tuberculosis
结局指标
主要结局
Change in Safety parameters.
时间窗: 20 weeks
次要结局
- Time to symptomatic progressions at Weeks 12 and 24(24 weeks)