Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Telik6 个研究点分布在 1 个国家目标入组 50 人开始时间: 2004年2月1日最近更新: 2011年7月25日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 50
试验地点: 6
主要终点: Primary Objectives of the Study

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic 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

•18 years of age or older
•Histologically confirmed non-small cell lung cancer
•Stage IV or IIIB
•Measurable disease by RECIST
•ECOG performance status of 0-1
•Adequate liver and renal function
•Adequate bone marrow reserve

排除标准

•History of bone marrow transplantation or stem cell support
•Pregnant or lactating women

结局指标

主要结局

Primary Objectives of the Study

时间窗: Every 3 weeks

1. To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) 2. To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

次要结局

未报告次要终点

研究者

发起方

Telik

申办方类型

Industry

研究点 (6)

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