NCT00302471已完成1 期
A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Safety and tolerability of 4 weeks of MK0429 therapy.
研究概览
简要总结
This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.
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
- Double (Participant, Investigator)
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
- •Eligible patients must have:
- •Prostate cancer
- •Bone metastases without symptoms
- •Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression
排除标准
- •Prostate cancer-related bone pain
- •Previously received bisphosphonate therapy (e.g. zoledronate)
- •Received any investigational treatment within the last 30 days
研究组 & 干预措施
400 mg twice a day
Experimental
MK0429
干预措施: Comparator: MK0429 (Drug)
1600 mg twice a day
Experimental
MK0429
干预措施: Comparator: MK0429 (Drug)
200 mg twice a day
Experimental
MK0429
干预措施: Comparator: MK0429 (Drug)
800 mg twice a day
Experimental
MK0429
干预措施: Comparator: MK0429 (Drug)
结局指标
主要结局
Safety and tolerability of 4 weeks of MK0429 therapy.
时间窗: up to 14 days following last dose of medication
次要结局
- Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429(4 weeks)
- Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks](4 weeks and 8 weeks)
研究者
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