NCT01929655已完成2 期
A Single-arm, Open-label, Multicenter, Phase II Study of BAY88-8223 in the Treatment of Japanese Patients With Symptomatic Castration-resistant Prostate Cancer (CRPC) With Bone Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 49
- 主要终点
- Percentage of change in total alkaline phosphatase from baseline at 12 weeks
研究概览
简要总结
To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing.
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Multiple bone metastases
- •Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain.
- •Best standard of care(BSoC) is regarded as the routine standard of care.
- •Exclusion Criteria :
- •Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
- •History of visceral metastasis, or presence of visceral metastasis
排除标准
- 未提供
研究组 & 干预措施
Radium-223 dichloride
Experimental
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Percentage of change in total alkaline phosphatase from baseline at 12 weeks
时间窗: Baseline and 12 weeks
次要结局
- The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment(24 weeks)
- The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks(12 weeks)
- Percentage of change in total alkaline phosphatase at the end of treatment(Baseline and 24 weeks)
- Percentages of change in bone ALP at 12 weeks(Baseline and 12 weeks)
- Overall survival(3 years)
- Number of participants with abnormal laboratory values(36 weeks)
- Percentages of change in bone ALP at the end of treatment(Baseline and 24 weeks)
- Percentages of change in biomarkers of bone turnover at each time point(Baseline and 36 weeks)
- The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks(12 weeks)
- Time to prostate specific antigen progression(24 weeks)
- The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment(24 weeks)
- Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability(3 years)
- Incidence of treatment-emergent adverse events (TEAEs)(24 weeks plus 30 days)
研究者
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