NCT00132522已完成1 期
A Study to Find the Highest Dose of Biological Study Drug (EMD 273066) That Can Be Given Safely to Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-Small Cell Lung Cancers When First Given a Low Dose of Cyclophosphamide
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- efficacy
研究概览
简要总结
This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.
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
- •Recurrent non-small cell lung, colorectal, ovarian or prostate cancer
- •No more than two lines of prior chemotherapy
- •Positive EpCAM expression
- •Karnofsky Performance Status > 70%
- •Adequate laboratory results
- •Normal cardiac stress test
排除标准
- •Evidence of brain metastases
- •Pregnant or lactating females
- •Significant infection
- •Prior receipt of EMD 273066
- •Unable to interrupt anti-hypertensive medications 2 days prior to and through each cycle of study medication administration
- •Uncontrolled hypertension
- •Previous diagnosis of Addison's disease
- •Previous diagnosis of an autoimmune disease
- •Organ transplant
- •Insulin-dependent diabetes
- •History of acute pancreatitis
- •Congestive heart failure
研究组 & 干预措施
Arm 1
Experimental
干预措施: EMD 273066 (Drug)
结局指标
主要结局
efficacy
时间窗: various timepoints
safety
时间窗: various timepoints
次要结局
未报告次要终点
研究者
研究点 (5)
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