NCT00034827已完成2 期
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer, or Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 172
- 试验地点
- 31
- 主要终点
- Overall objective response and clinical benefit response
研究概览
简要总结
CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.
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
- •Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer.
- •No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer.
- •Original or recent tumor tissue must be available.
- •Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks.
- •Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor).
- •Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug.
排除标准
- •Unstable medical condition
- •prior chemotherapy within 4 week of screening
- •series infection
- •other tumor types
- •ECOG performance status of 3 or 4.
结局指标
主要结局
Overall objective response and clinical benefit response
次要结局
- Time to objective response, duration of response, time to progression and survival
研究者
研究点 (31)
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