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临床试验/NCT00047762
NCT00047762已完成1 期

Open-Label, Multicenter, Dose-Escalation Study in Subjects w/Advanced Colorectal Cancer to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tarceva in Combination w/5-Fluorouracil, Leucovorin, and Irinotecan and of Bevacizumab in Combination w/Tarceva, 5-Fluorouracil, Leucovorin, and Irinotecan

Genentech, Inc.3 个研究点 分布在 1 个国家开始时间: 2002年10月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
试验地点
3

研究概览

简要总结

The purpose of this study is test the safety of Tarceva, find the best dose, and see what effects (good and bad) it has on you and your colorectal cancer. The effects of Tarceva will be evaluated in combination with 5-fluorouracil, leucovorin, and irinotecan, with or without Bevacizumab.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • •Subjects must fulfill all of the following criteria to be eligible for study entry:
  • •Signed informed consent
  • •At least 18 years of age
  • •Histologically confirmed metastatic colorectal adenocarcinoma of the colon or rectum
  • •Resected or biopsied primary tumors or metastatic site will serve as the basis for histologic confirmation.
  • •Measurable disease (defined as at least one dimension >2 cm [>1 cm on spiral CT scans])
  • •ECOG performance status of 0 or 1
  • •Life expectancy >3 months
  • •Use of an effective means of contraception in men and in women of childbearing potential
  • •Ability to comply with study and follow-up procedures

排除标准

  • 未提供

研究者

申办方类型
Industry

研究点 (3)

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