A Phase 2 Study of EKB-569 in Subjects With Advanced Non-Small Cell Lung Cancer

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 44 人开始时间: 2003年8月25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: 44

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 non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either 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 non-small cell lung 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
•Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy

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 radiotherapy to >25% of bone marrow
•Prior epidermal growth factor receptor-targeting therapy

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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