JPRN-jRCT1080221825已完成4 期
Open-Label access Protocol of Denosumab for Subjects with Advanced Cancer
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 129 人开始时间: 2012年6月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subject 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.
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 methods 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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进行中（未招募）
不适用
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Open-Label Access Protocol of Denosumab for Subjects with Advanced CancerBone Metastases in Subjects with Advanced Breast Cancer and Bone Metastases in Men with Hormone-Refractory Prostate CancerMedDRA version: 16.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: LLT Classification code 10005993 Term: Bone metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002114-36-HUAmgen Inc129
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