NCT00976755已完成2 期
Everolimus First-line Therapy in Non-rapidly Progressive Castration Resistant Prostate Cancer (CRPC). A Multicenter Phase II Trial.
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
- 37
- 试验地点
- 12
- 主要终点
- Progression-free survival (PFS) at 12 weeks
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the progression-free survival at 12 weeks of patients with non-rapidly progressive castration-resistant prostate cancer treated with everolimus as first-line therapy.
- Assess the activity and safety of this regimen in these patients.
Secondary
- Determine the progression-free survival at 24 weeks of patients treated with this regimen.
- Determine the percentage of PSA response from baseline to 12 weeks in patients treated with this regimen.
- Determine the changes in PSA-doubling time in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: Everolimus
Experimental
Everolimus:
10mg daily
干预措施: everolimus (Drug)
结局指标
主要结局
Progression-free survival (PFS) at 12 weeks
时间窗: at 12 weeks
PFS at 12 weeks is defined as the absence of disease progression or death at 12 weeks after start of treatment.
次要结局
- PFS at 24 weeks(at 24 weeks)
- Progression-free survival(from start of treatment until progression or death of any cause)
- Adverse events (AEs) according to NCI CTCAE v. 3.0(from start of treatment until progression or death of any cause)
- PSA response(50% and 30%, best and at 12 weeks)
- Changes in PSA-doubling time(Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response)
- Tumor assessment of measurable disease according to RECIST v1.1 criteria(The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated.)
- Tumor assessment of bone lesions(at 12 weeks.)
研究者
研究点 (12)
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