Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 484
- 主要终点
- Change in Lean Body Mass
研究概览
简要总结
The administration of Anamorelin in patients with Stage III-IV 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, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.
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
- •Documented diagnosis of unresectable Stage III or Stage IV NSCLC
- •Patients may be receiving maintenance chemotherapy
- •Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization
- •Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization
- •Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2
- •Body mass index ≤30 kg/m2
- •Life expectancy of >4 months at time of screening
- •ECOG performance status ≤2
- •Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal
- •Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute
- •Ability to understand and comply with the procedures for the HGS evaluation
- •If a 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
- •Other forms of lung cancer (e.g., small cell, mesothelioma)
- •Women who are pregnant or breast-feeding
- •Known HIV, hepatitis (B&C), or active tuberculosis
- •Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; 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 uncontrolled diabetes mellitus
- •Has untreated clinically relevant hypothyroidism
- •Has known or symptomatic brain metastases
- •Receiving strong CYP3A4 inhibitors within 14 days of randomization
- •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
- •Has had previous exposure to Anamorelin HCl
- •Patients actively receiving a concurrent investigational agent
研究组 & 干预措施
100 mg QD
Anamorelin HCL 100 mg will be administered daily
干预措施: Anamorelin HCl (Drug)
Placebo
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
Change in Lean Body Mass
时间窗: Change in Lean Body Mass from Baseline Over 12 Weeks
Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Change in Handgrip Strength
时间窗: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
次要结局
- Change in FACIT-F Fatigue Domain Score(Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks)
- Change in A/CS Domain Score(Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks)
- Change in Body Weight(Change in Body Weight from Baseline Over 12 Weeks)