EUCTR2010-021846-23-GB进行中(未招募)1 期
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- Amgen Inc
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147
- •Subjects must sign the informed consent before any study specific procedures are performed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Developed sensitivity to mammalian cell derived drug products during the 20050147 study
- •Currently receiving any unapproved investigational product other than denosumab
- •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
研究者
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