EUCTR2006-006964-48-FR进行中（未招募）1 期
An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects with Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone
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
- 34
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
- 性别
- All
入选标准
- •4.1.1 Adult subjects (=18 years of age) with histologically confirmed giant cell tumor who have measurable (defined as being at least 10 millimeters [mm] in size in the greatest dimension) recurrent GCT confirmed by radiology or unresectable GCT
- •4.1.2 ECOG performance status of 0, 1, or 2
- •4.1.3 Before any study- specific procedure is performed, the appropriate written informed consent must be obtained.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •4.2.1 Subjects for whom palliative resection is planned: planned surgical intervention of the affected limb/area 28 days or less after administration of the first dose of denosumab
- •4.2.2 Radiation to affected region within 28 days before enrollment to study
- •4.2.3 Known diagnosis of osteosarcoma or brown tumor of bone [osteitis fibrosa cystica])
- •4.2.4 Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
- •4.2.5 Prior treatment with denosumab
- •4.2.6 Concurrent treatment with IV or oral bisphosphonates, calcitonin or interferon alpha- 2a
- •4.2.7 Females of child- bearing potential who are not willing to use adequate contraceptive methods while on study and for 12 months post study, are pregnant (eg, positive urine or serum HCG test), or breast feeding
- •4.2.8 Men who are not willing to use adequate contraceptive methods while on study and for 12 months post- study
- •4.2.9 Thirty days or less since receiving an investigational product or device in another clinical study. Current enrollment in another clinical study is not permitted unless the purpose of the study is for long- term follow- up/survival data
- •4.2.10 Known sensitivity to any of the products to be administered during dosing
研究者
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