A Phase II, Open-Label Study of Ispinesib in Subjects With Locally Advanced or Metastatic Platinum-Refractory or Platinum-Relapsed Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 12
- 主要终点
- Assessment of Overall Response Rate of tumor.
研究概览
简要总结
This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Must have received only one prior platinum-based chemotherapy regimen.
- •Blood tests will be done to check if blood counts are adequate for taking part in the study.
排除标准
- •Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
- •Females who are pregnant.
- •Any unstable, pre-existing major medical condition or history of other cancers.
- •Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
结局指标
主要结局
Assessment of Overall Response Rate of tumor.
次要结局
- Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters.