NCT00757757终止1 期
A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
研究概览
简要总结
This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
- •18 years old and over
排除标准
- •Plan to be on cytotoxic or biologic therapy during study
- •Active dental problems
- •Active heart complications
- •Active infection
- •Patients with moderate to severe swelling due to fluid
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
MCS110
Experimental
干预措施: MCS110 (Drug)
结局指标
主要结局
Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
时间窗: every cycle - (cycle = 28 days)
Type and frequency of adverse drug reactions and serious adverse drug reactions
时间窗: every cycle - (cycle = 28 days)
次要结局
- Change in markers of bone resorption and formation (pre- vs. post-treatment)(3 months)
研究者
研究点 (2)
Loading locations...
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