A Phase 2 Study of LY573636-Sodium Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as Third-line Treatment in Patients With Unresectable, Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Time to Progression
研究概览
简要总结
The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans 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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic non-small-cell lung cancer
- •At least 18 years of age
- •Have received 2 previous treatment regimens for metastatic non-small-cell lung cancer
排除标准
- •Serious pre-existing medical conditions
- •Previous cancer (except skin cancer, excluding melanoma)
- •Have received 3 or more previous treatment regimens for metastatic non- small-cell lung cancer
- •Active treatment with Coumadin
研究组 & 干预措施
LY573636
干预措施: LY573636-sodium (Drug)
结局指标
主要结局
Time to Progression
时间窗: First dose to measured progressive disease or death from study disease up to 10.35 months
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
次要结局
- Progression-Free Survival(First treatment dose to measured progressive disease or death from any cause up to 10.35 months)
- Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)(First treatment dose to measured progressive disease or death due to any cause up to 10.35 months)
- Duration of Response(Time of response to progressive disease or death up to 10.35 months)
- Duration of Stable Disease(Time from documented stable disease or better to first date of progressive disease up to 10.35 months)
- Pharmacokinetics: Maximum Concentration (Cmax) of LY573636(Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle))
- Overall Survival Time(First treatment dose to death due to any cause up to 25.23 months)
- Number of Participants With Adverse Events (Safety)(First treatment dose up to 25.23 months)