EUCTR2011-002114-36-BE进行中（未招募）1 期
Open-Label Access Protocol of Denosumab for Subjects with Advanced 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
- 129
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 was previously enrolled in a denosumab phase 3 study and
- •participated in the Open-label Extension portion of that study.
- •- Subject or subject’s legally acceptable representative has provided
- •informed consent.
- •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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •- Subject is of child bearing potential and planning to become pregnant
- •within 7 months after the end of treatment.
- •- Subject is of child bearing potential and is not willing to use, in
- •combination with her partner, two highly effective method of contraception during treatment and for 7 months after the end of treatment.
- •- Subject has known sensitivity to any of the products to be administered during dosing.
- •- Subject will not be available for protocol-required study visits or
- •procedures, to the best of the subject and investigator’s knowledge.
- •- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
研究者
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