NCT02432690终止2 期
A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
This was an open-label, single-arm, Phase II study in which amcasertib (BBI503) was administered to adult, asymptomatic patients with recurrent ovarian cancer who had elevated CA-125.
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
- All
- 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
Arm A
Experimental
干预措施: BBI503 (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks
Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease). DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).
次要结局
- Progression Free Survival (PFS)-6(The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months)
- Progression Free Survival (PFS)(The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 18 months)
- Objective Response Rate (ORR)(From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months)
- Overall Survival (OS) at 6 Months(4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months)
- Number of Patients With Adverse Events(The time from the date of first treatment, while the patient is taking amcasertib, and for 30 days after stopping therapy, an average of 4 months.)
研究者
研究点 (1)
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