NCT00849290已完成2 期
AN OPEN LABEL, SINGLE ARM TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (APC8015F) FOR MEN WITH OBJECTIVE DISEASE PROGRESSION ON PROTOCOL D9902 PART B
Dendreon58 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2004年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 58
- 主要终点
- Safety of APC8015F by Review of Reported Adverse Events
研究概览
简要总结
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
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
- •Objective disease progression
- •Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)
排除标准
- •Infection requiring IV antibiotics
- •Treatment with anticancer interventions within 14 days prior to enrollment
- •Any medical condition which could compromise the study's objectives (discretion from sponsor)
结局指标
主要结局
Safety of APC8015F by Review of Reported Adverse Events
时间窗: periodically over 24 months
All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
次要结局
未报告次要终点
研究者
研究点 (58)
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