NCT00036647已完成3 期
A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
OSI Pharmaceuticals97 个研究点 分布在 13 个国家目标入组 731 人开始时间: 2001年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 731
- 试验地点
- 97
研究概览
简要总结
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
- •Must have evidence of disease (clinical or radiological).
- •Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
- •If the patient has had surgery, the surgery was at least 2 weeks ago.
- •Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.
- •If the patient received radiation therapy, treatment was at least 4 weeks ago.
排除标准
- 未提供
研究者
研究点 (97)
Loading locations...
相似试验
已完成
3 期
OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.Pancreatic CancerNCT00040183OSI Pharmaceuticals569
已完成
2 期
OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell CancerHead and Neck CancerNCT00076310M.D. Anderson Cancer Center50
已完成
2 期
Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal CancerNeoplasm MetastasisColorectal CancerNCT00123851Dana-Farber Cancer Institute32
已完成
2 期
Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the KneeOsteoarthritis of the KneeNCT01768975Olatec Therapeutics LLC79
已完成
2 期
OSI-774 (Erlotinib, Tarceva) in Elderly PatientsNon-Small Cell Lung CancerNCT00200395Montefiore Medical Center30