NCT03057314终止1 期
Exploratory, Open Label Study to Improve Function and Welfare of Late-stage Cancer Subjects by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessing a change in Pain Visual Analog Score (VAS score)
研究概览
简要总结
To improve the function and welfare of late stage solid cancer subjects by:
- enabling subjects to benefit from a potentially promising drug under development
- assessing initial evidence of improvement in Pain VAS score
- assessing initial improvement in Performance Status (PS)
- assessing initial improvement in oxygen saturation whenever it is feasible
详细描述
To improve the function and welfare of late stage solid cancer subjects by:
- enabling subjects to benefit from a potentially promising drug under development
- assessing initial evidence of improvement in Pain VAS score
- assessing initial improvement in Performance Status (PS)
- assessing improvement in oxygen saturation whenever it is feasible/ dyspnea measurement (Modified Borg Scale)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •Concurrent treatment with acute anti-cancer therapy
- •Hypercalcemia (serum calcium concentration > 12.0 mg/dL)
- •Clinical Significant Cardiovascular Disease
- •Known alcohol or drug abuse
- •Any psychiatric condition that would prohibit understanding or rendering of Informed Consent
- •Active Participation in Clinical Trial in the last 2 weeks prior to inclusion
- •Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
研究组 & 干预措施
Amorphous calcium carbonate
Experimental
The investigation product will include:
- ACC tablets, containing 200 mg elemental calcium
- 1% ACC (i.e. 0.3% calcium) + 5 mL Water for Injection, as a sterile suspension
干预措施: Amorphous Calcium Carbonate (Drug)
结局指标
主要结局
Assessing a change in Pain Visual Analog Score (VAS score)
时间窗: Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
Visual Analog scale ranging from 0 up to 10 meaning that ; 0 = no pain(min) 10=unbearable pain(max)
次要结局
- Assessing a change in Performance Status (PS): ECOG scale(Baseline and on weeks 0,1,2,3,4,5,8 and on week 11)
研究者
研究点 (1)
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