NCT00950911已完成3 期
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Participants Survived
研究概览
简要总结
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subjects currently enrolled in study 20050103, 20050136, or 20050244
- •Subjects must sign the informed consent before any study specific procedures are performed
排除标准
- •Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study
- •Currently receiving any unapproved investigational product other than denosumab
- •Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
- •Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment
- •Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
- •Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
研究组 & 干预措施
1
Experimental
干预措施: amg 162 (Drug)
结局指标
主要结局
Number of Participants Survived
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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