A Phase II Study of SB939 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well SB939 works in treating patients with recurrent or metastatic prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy, as measured by PSA response and progression-free survival, of HDAC inhibitor SB939 in patients with recurrent or metastatic castration-resistant prostate cancer.
Secondary
- To determine the objective response and response duration in patients with measurable disease at baseline.
- To determine the tolerability and toxicity of this drug in these patients.
- To determine the number of circulating tumor cells at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment).
- To explore potential molecular factors predictive of response by assessment of archival prostate tumor tissue.
- To explore ERG and PTEN expression on circulating tumor cells as a potential prognostic and predictive marker for response to this drug.
- To determine time to PSA and time to objective progression in these patients.
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
SB939
SB939 given orally every other day 3 times a week (i.e. Monday /Wednesday /Friday, or Tuesday /Thursday / Saturday) for 3 consecutive weeks followed by one week off-dosing. A treatment cycle is 4 weeks (28 days).
干预措施: HDAC inhibitor SB939 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: end of study
Used as an indicator of efficacy, patients with PSA response will have length of progression free survival calculated.
PSA response
时间窗: each cycle
Each patient will have PSA response calculated. Required at the end of every cycle.
次要结局
- Change in circulating tumor cells during study compared to baseline(each cycle)
- Comparison of TMPRSS2-ERG fusion and PTEN deletion in circulating tumor cells(each cycle)
- Comparison of two systems for counting circulating tumor cells(end of study)
- Safety(each cycle)
- Duration of response(every other cycle)
- Objective response rate(every other cycle)