EUCTR2009-009374-27-GB进行中（未招募）1 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
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
- 35
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 enrolled in study 20050103, 20050136, or 20050244
- •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) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
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
研究者
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