A Randomized, Phase II Study of Two Dose Levels of ATN-224 in Patients With Biochemically Relapsed, Early Stage Prostate Cancer Not on Hormone Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
研究概览
简要总结
This is a multicenter, randomized, phase II study of the safety and efficacy of two dose levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the absence of detectable disease. Patients will be randomized (1:1) after confirmation of eligibility requirements. The primary endpoint is to determine the proportion of patients who do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50% increase in PSA and >5 ng/mL from baseline or post-treatment nadir if lower than baseline, confirmed by another PSA at least 28 days later.
详细描述
ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be anti-angiogenic and to have activity against prostate cancer cell lines. ATN-224 has the potential to affect the progression of prostate cancer by mechanisms that include both antiangiogenic and antitumor pathways. ATN-224 may change the time to overt metastatic disease in patients with rising PSA as the only manifestation of disease after treatment with curative intent and delay the need for hormonal therapies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High Dose
ATN-224 dose 300mg
干预措施: ATN-224 (Drug)
Low Dose
ATN-224 dose: 30mg
干预措施: ATN-224 (Drug)
结局指标
主要结局
Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
时间窗: 24 weeks
次要结局
- Establish the safety of the two dose levels of ATN-224(Ongoing)
- Determine the proportion of patients with a 50% reduction from baseline of PSA confirmed by a second PSA value at least 28 days later(End of Study)
- Determine the change in PSA doubling time (PSA-DT) from baseline(End of Study)
- Determine the maximal % decrease in PSA after treatment(End of Study)
- Determine the time to PSA progression (as defined by this protocol)(End of Study)
- Determine the 24-week rate of metastases(24 weeks)
- Determine the effect of ATN-224 treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red blood cells(End of Study)