NCT00286806已完成1 期
An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy
Ascenta Therapeutics4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Number of participants with adverse events.
研究概览
简要总结
This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Rising PSA, as defined by increasing levels on at least two consecutive assessments
- •ECOG performance status 0 or 1
- •Adequate hematologic function
- •Adequate liver and renal function
- •Able to swallow and retain oral medication.
排除标准
- •Received prior chemotherapy for HRPC.
- •Concurrent therapy for the treatment of prostate cancer.
- •Clinical signs or symptoms of CNS metastases
- •Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.
- •Active secondary malignancy or history of other malignancy within the last 5 years.
- •Failure to recover from toxicities related to prior therapy.
- •Uncontrolled concurrent illness.
结局指标
主要结局
Number of participants with adverse events.
次要结局
- Complete or partial remission of disease
研究者
研究点 (4)
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