NCT00884715终止1 期
Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Endo Pharmaceuticals0 个研究点目标入组 10 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 主要终点
- Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
研究概览
简要总结
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
详细描述
This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed tumor
- •documented evidence of carcinoid syndrome
- •life expectancy of at least 6 months
- •previous positive octreotide scan
- •received stable doses of octreotide injections
- •performance status of 0-2 on the ECOG performance scale
排除标准
- •poorly differentiated or high grade neuroendocrine tumor
- •significant cv, hepatic, renal or other disease
研究组 & 干预措施
1 implant
Experimental
117 mg Octreotide implant
干预措施: Octreotide (Drug)
2 implants
Experimental
234 mg Octreotide implant
干预措施: Octreotide (Drug)
结局指标
主要结局
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
时间窗: 9 months
次要结局
- safety and tolerability of the implants(9 months)
研究者
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