A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Genzyme, a Sanofi Company0 个研究点目标入组 17 人开始时间: 2006年8月1日最近更新: 2016年8月26日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 17
主要终点: Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

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

•Confirmed non small cell lung cancer (stage IIIB-IV)
•Life expectancy greater than 12 weeks
•At least 1 measurable lesion greater than 10mm in smallest diameter.

排除标准

•Prior treatment with anticancer agent
•Brain metastases
•Major surgery within last 4 weeks

结局指标

主要结局

Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

次要结局

Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered(Predetermined timepoints after dose administration)
Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

研究者

发起方

Genzyme, a Sanofi Company

申办方类型

Industry

责任方

Sponsor

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