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
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 37
- 主要终点
- Percentage of Participants With Giant Cell Tumor Response
研究概览
简要总结
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18 years and older
- •Histologically confirmed and measurable giant cell tumor (GCT)
- •Recurrent GCT confirmed by radiology or unresectable GCT
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
排除标准
- •Pateints for whom surgery to the affected limb/area is planned within 27 days after receiving 1st dose of denosumab
- •Radiation to affected region within 28 days before enrollment to study
- •Known diagnosis of osteosarcoma or brown tumor of bone
- •Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
- •Concurrent treatment with bisphosphonates, calcitonin, or interferon.
- •Other criteria also apply.
结局指标
主要结局
Percentage of Participants With Giant Cell Tumor Response
时间窗: From enrollment until 25 weeks
A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent \< 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.
次要结局
- Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine(Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81)
- Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)(Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81)
- Number of Participants With Adverse Events (AEs)(From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months)
- Serum Denosumab Trough Concentrations(Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.)
- Number of Participants With Anti-Denosumab Antibodies(From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.)