NCT01611558已完成2 期
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Bristol-Myers Squibb33 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年8月21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
- 40
- 试验地点
- 33
- 主要终点
- Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
研究概览
简要总结
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
详细描述
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
时间窗: Day 1, first dose, to within 90 days of last dose in Induction Phase
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.
次要结局
- Best Overall Response Rate (BORR)(From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years))
- Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation(From first dose to within 90 days of last study dose)
研究者
研究点 (33)
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