A Phase 2 Study of LY573636-Sodium as Treatment for Patients With Platinum-Resistant Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)
研究概览
简要总结
The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and CA-125 tests will be done before the first dose and then after every other treatment.
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
- •Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- •At least 18 years old
- •Have received at least one but no more than 2 systemic treatment regimens containing platinum (does not include regimens received before surgery for this cancer)
- •Have platinum-resistant disease
排除标准
- •Have received more than 2 systemic treatment regimens for platinum-resistant disease
- •Serious pre-existing medical conditions
- •Actively receiving warfarin (Coumadin) for treatment of venous thrombosis or other prothrombotic conditions
研究组 & 干预措施
LY573636
LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
干预措施: LY573636-sodium (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)
时间窗: Baseline to measured progressive disease up to 12.68 months
Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
次要结局
- Progression Free Survival(Baseline to measured progressive disease or death due to any cause up to 21.26 months)
- Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)(Baseline to measured progressive disease up to 21.26 months)
- Pharmacokinetics: Maximum Concentration (Cmax) of LY573636(Predose up to 2 hours postdose in Cycles 1 and 2)
- Overall Survival(First treatment to death due to any cause up to 42.91 months)
- Duration of Response(Time of response to time of measured progressive disease up to 12.68 months)
- Duration of Stable Disease(Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months)
- Number of Participants With Adverse Events (Safety)(First treatment dose up to 43.91 months)