Study Evaluating EKB-569 in Advanced Colorectal Cancer

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 63 人开始时间: 2003年11月13日最近更新: 2009年8月21日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 63

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens).

The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.

Secondary objectives include:

To further evaluate the safety of EKB-569
To explore additional clinical activity parameters
To explore subject survival
To evaluate the pharmacokinetics of EKB-569
To assess subject reported outcomes

EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.

研究设计

研究类型: Interventional
分配方式: Non 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

•Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
•Previous histologic diagnosis of adenocarcinoma of the colon or rectum
•EGFR expression by immunohistochemical analysis (must be > or = 20% positive tumor cells in prior tumor biopsy specimens)

排除标准

•Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
•Prior epidermal growth factor receptor-targeting therapy
•Known central nervous system (CNS) metastases

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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