NCT00535015终止2 期
A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC
Anaborex6 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2007年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate
研究概览
简要总结
The purpose of this study is to determine whether Betamarc is effective in improving the appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.
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
- •Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery.
- •Treatment plan includes a platinum-based doublet chemotherapy.
- •ECOG 0, 1 or
- •Self-reported loss of body weight or anorexia.
- •Serum C-reactive protein ≥5 mg/L.
- •Life expectancy of at least 6 months.
- •Adequate bone marrow, liver and renal function.
- •Normal serum potassium.
- •Ability to comply with the study requirements and give written informed consent.
排除标准
- •Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product.
- •Concomitant therapy with an appetite stimulant.
- •History of poorly controlled hypertension or congestive heart failure.
- •Any implanted devices that could interfere with DXA scanning.
- •Prolongation of QT interval.
- •History of additional risk factors for torsades de pointe.
- •Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives.
- •Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control.
- •Any second malignancy which might confound the interpretation of safety or efficacy assessments.
- •Any condition which increases the patient's risk for participating in the study.
结局指标
主要结局
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate
时间窗: 25 weeks
次要结局
- Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination(25 weeks)
研究者
研究点 (6)
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