A Phase II, Open-Label Study of Ispinesib in Subjects With Platinum/Taxane-Refractory or Resistant Relapsed Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days
研究概览
简要总结
The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24 hour 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have a screening CA-125 of greater than or equal to 40 U/ml.
- •Must have received only one prior platinum/taxane-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 or nursing.
- •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
Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days
时间窗: once every 21 days
次要结局
- Assess safety/tolerability, progression-free survival, time-to-response, response duration, and characteristics of Ispinesib administered as an infusion once every 21 days(once every 21 days)