A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 111
- 主要终点
- uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
研究概览
简要总结
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma
- •Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma
- •Currently receiving IV bisphosphonates
- •Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine
- •Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
排除标准
- •More than 2 prior skeletal related events (SRE)
- •Known brain metastases
- •Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- •Active dental or jaw conditions which requires oral surgery
- •Non-healed dental/oral surgery
- •Prior administration of AMG 162
- •Evidence of impending fracture in weight bearing bones
- •Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.
研究组 & 干预措施
IV Bisphosphonates q 4 weeks
This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks.
干预措施: IV Bisphosphonate q 4 weeks (Drug)
180 mg AMG 162 (SC) q 12 weeks
This is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks.
干预措施: AMG 162 180 mg (SC) q 12 weeks (Genetic)
180 mg AMG 162 (SC) q 4 weeks
This is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks.
干预措施: AMG 162- 180 mg q 4 weeks (Genetic)
结局指标
主要结局
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
时间窗: 13 weeks
Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.
次要结局
- uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25(25 weeks)
- Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25(Baseline, week 25)
- Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol(Day 1, week 25)
- Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol(Day 1, week 25)
- Percent Change of Serum CTX From Baseline to Week 25(Baseline, week 25)
- Time to First Skeletal Related Event(Day 1, week 25)
- Skeletal Related Events(Day 1, week 25)
- Hypercalcemia(Day 1, week 25)