A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 255
- 主要终点
- Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
研究概览
简要总结
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed breast adenocarcinoma
- •At least one bone metastasis
排除标准
- 未提供
研究组 & 干预措施
Denosumab 60 mg every 12 weeks
Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
干预措施: Denosumab (Biological)
Denosumab 120 mg every 4 weeks
Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
干预措施: Denosumab (Biological)
Denosumab 180 mg every 4 weeks
Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
干预措施: Denosumab (Biological)
IV bisphosphonates every 4 weeks
Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.
干预措施: IV Bisphosphonates (Drug)
Denosumab 180 mg every 12 weeks
Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
干预措施: Denosumab (Biological)
Denosumab 30 mg every 4 weeks
Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
干预措施: Denosumab (Biological)
结局指标
主要结局
Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
时间窗: Baseline and Week 13
Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.
次要结局
- Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)(Baseline and Week 25)
- Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25(Baseline and Week 25)
- Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline(Baseline to Week 57)
- Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)(Baseline and week 13)
- Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in P1NP(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)(Baseline and Week 25)
- Percent Change From Baseline to Week 13 in Osteocalcin(Baseline and Week 13)
- Percent Change From Baseline to Week 25 in Osteocalcin(Baseline and Week 25)
- Time to First Skeletal Related Event(Day 1 to Week 25)
- Number of Participants With Skeletal Related Events(From Day 1 to Week 25)
- Number of Participants With Hypercalcemia(Day 1 to Week 57)