NCT00081601已完成2 期
An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
Cephalon2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
详细描述
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
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
- •at least 18 yrs of age
- •diagnosis of adenocarcinoma of the prostate
- •no detectable metastatic disease as assessed by bone and CT scans
- •has increasing serum PSA concentrations
- •life expectancy of at least 3 months
- •ECOG of 0 or 1
- •has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
排除标准
- •has asymptomatic disease
- •has active GI ulceration or bleeding
- •has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
- •bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL
- •hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL
- •receiving treatment for HIV with protease inhibitors
- •has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
- •has used investigational drug with previous one month
研究者
研究点 (2)
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