NCT00777959已完成2 期
A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Number of dose limiting toxicities (DLTs)
研究概览
简要总结
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.
详细描述
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.
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
- •Confirmed adenocarcinomas of the prostate.
- •Evidence of metastatic disease
- •Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
- •PSA level is greater or equal to 7 ng/ml.
- •ECOG performance status less than or equal to 1
- •Exclusion Criteria :
- •Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
- •Prior chemotherapy for prostate cancer
- •Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
- •Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
- •Patient has pain related to prostate cancer that warrants the initiation of chemotherapy
排除标准
- 未提供
研究组 & 干预措施
Open Label
Experimental
ridaforolimus (MK8669)+ bicalutamide
干预措施: open-label ridaforolimus (MK8669) (Drug)
Ridaforolimus
Experimental
ridaforolimus (MK8669)+ bicalutamide
干预措施: ridaforolimus (MK8669) (Drug)
结局指标
主要结局
Number of dose limiting toxicities (DLTs)
时间窗: Day 1 to Day 35
30% Prostate specific antigen (PSA) decline within 12 weeks
时间窗: 12 weeks
次要结局
- Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus(30 Minutes to 24 hour postdose)
- Number of patients with progression free survival (PFS)(12 weeks)
- Prostate specific antigen (PSA) response rate(12 weeks)
- Time to prostate specific antigen (PSA) progression(12 weeks)
研究者
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