NCT00072631已完成2 期
A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy
OSI Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2003年11月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
研究概览
简要总结
The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.
详细描述
Only patients with 0 to 1 performance status on the ECOG scale are eligible.
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 diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
- •Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
- •Measurable disease per RECIST criteria.
- •Adequate bone marrow, hepatic and renal function.
排除标准
- •Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
- •Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
- •Known hypersensitivity to minocycline.
- •History of serious cardiac disease that is not controlled.
- •Serious eye conditions.
- •Prior treatment with inhibitors of EGFR of any kind.
研究组 & 干预措施
1 erlotinib
Experimental
干预措施: Tarceva (Trademark) (erlotinib HCl, OSI-774) (Drug)
结局指标
主要结局
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
时间窗: 3 years
次要结局
- Feasibility of correlating objective response rate and duration of response to grade of rash(3 years)
研究者
研究点 (1)
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