NCT00093457已完成2 期
A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 14
- 主要终点
- Prostate-specific antigen response and/or progression
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.
详细描述
OBJECTIVES:
- Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate.
Secondary
- Determine the objective response rate and duration of response in patients treated with this drug.
- Determine the tolerability and toxicity of this drug in these patients.
- Determine time to treatment failure and overall survival in patients treated with this drug.
- Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients.
OUTLINE: This is a non-randomized, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
结局指标
主要结局
Prostate-specific antigen response and/or progression
时间窗: 2 years
次要结局
- Tolerability and toxicity(2 years)
- Time to treatment failure and overall patient survival(2 years)
- Objective response and/or progression(2 years)
研究者
研究点 (14)
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