Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- Percentage of Patients With PSA Doubling Time >=3 Months.
研究概览
简要总结
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.
详细描述
This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days (Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be evaluated prior to each cycle and % fetal hemoglobin will be evaluated prior to each odd cycle (excluding Cycle 1). Patients will be treated until clinical progression up to a maximum of 12 cycles. A total of 35 patients with advanced metastatic HRPC will be enrolled in this trial.
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 —（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
1
azacitidine for injectable suspension
干预措施: azacitidine for injectable suspension (Drug)
结局指标
主要结局
Percentage of Patients With PSA Doubling Time >=3 Months.
时间窗: Until progression or up to a maximum of 12 cycles
To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time \>3= months.
次要结局
- PSA Response Rate(Every 8 weeks for 1 year.)
- Objective Response Rate by Recist (ORR)(Every 8 weeks for 1 year.)
- Progression-free Survival(Up to 1.5 year.)
- 1-year Overall Survival (OS)(Up to 1 year.)
- Changes in Fetal Hemoglobin (HbF) With Time.(Up to 1 year.)