Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an Objective Overall Response
研究概览
简要总结
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.
详细描述
Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).
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
- •Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
- •Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.
排除标准
- •Serious pre-existing medical condition.
- •Have active central nervous system or leptomeningeal metastasis.
- •Current hematologic malignancies, acute or chronic leukemia.
- •Receiving Warfarin (Coumadin).
- •Have a history of radiation therapy involving more than 25% of the bone marrow.
研究组 & 干预措施
LY573636-sodium
干预措施: LY573636-sodium (Drug)
结局指标
主要结局
Percentage of Participants With an Objective Overall Response
时间窗: Baseline to measured progressive disease or death from any cause up to 12 months
Objective overall 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. It 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
- Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)](Baseline to measured progressive disease or death from any cause up to 12 months)
- Duration of Stable Disease(Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months)
- The Percentage of Participants With Exposures in the Target Range(After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle))
- Duration of Overall Response(Time of response to progressive disease or death up to 12 months)
- Progression-free Survival(Baseline to measured progressive disease or death from any cause up to 12 months)
- Maximum Concentration (Cmax)(After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)])