NCT01395914已完成3 期
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 513
- 主要终点
- Percentage of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
详细描述
This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial
- •ECOG performance status ≤2
- •Life expectancy of >4 months at time of screening
- •If woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
- •Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures
排除标准
- •Women who are pregnant or breast-feeding
- •Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
- •Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol
- •Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded
- •Has an active, uncontrolled infection
- •Has known or symptomatic brain metastases
- •Receiving strong CYP3A4 inhibitors
- •Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
- •Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
- •Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl
研究组 & 干预措施
100 mg QD
Experimental
100 mg yellow coated, oval tablet; oral administration once daily
干预措施: Anamorelin HCl (Drug)
Placebo
Placebo Comparator
Placebo tablets identical in appearance to active tablets; oral administration once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-emergent Adverse Events
时间窗: Over the 12-week treatment period
To Evaluate the Safety and Tolerability of Anamorelin HCl.
次要结局
- Change in Handgrip Strength of the Non-Dominant Hand(Change in HGS from baseline of the original trial through Week 12 of this extension trial.)
- Change in A/CS Domain Score(Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial)
- Change in Body Weight(Change in body weight from baseline of the original trial through Week 12 of this extension trial.)
研究者
相似试验
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3 期
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)CachexiaNon-Small Cell Lung CancerNCT01387269Helsinn Therapeutics (U.S.), Inc484
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Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)CachexiaNon-Small Cell Lung CancerNCT01387282Helsinn Therapeutics (U.S.), Inc495
进行中（未招募）
不适用
A clinical trial studying the safety and effectiveness of the study drugAnamorelin HCl for treating cachexia (weight loss and muscle mass loss) in patients with Non-Small Cell Lung CancerEUCTR2010-023650-36-PLHelsinn Therapeutics (U.S.), Inc.350
进行中（未招募）
不适用
A clinical trial studying the safety and effectiveness of the study drugAnamorelin HCl for treating cachexia (weight loss and muscle mass loss) in patients with Non-Small Cell Lung Cancer.EUCTR2010-023650-36-ESHelsinn Therapeutics (U.S.), Inc.350
进行中（未招募）
1 期
A clinical trial studying the safety and effectiveness of the study drugAnamorelin HCl for treating cachexia (weight loss and muscle mass loss)in patients with Non-Small Cell Lung CancerEUCTR2010-023650-36-BEHelsinn Therapeutics (U.S.), Inc.350