NCT00836654已完成2 期
Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group
Neovii Biotech0 个研究点目标入组 258 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
研究概览
简要总结
The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •histological confirmed diagnosis cancer
- •symptomatic malignant ascites
- •EpCAM positive tumor
- •negative pregnancy
排除标准
- •acute or chronic infection
- •exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
- •previous treatment with mouse monoclonal antibodies
- •known or suspected hypersensitivity to Removab or similar antibodies
- •inadequate renal function
- •inadequate hepatic function (AST, ALt, GTP,< x ULN; bilirubin <1.5xULN)
- •Platelets > 80000 cells/mm3; absolute neutrophil count (ANC) < 1500 cells/mm3
- •BMI < 17
- •Patients with reduced nutritional status
- •Ileus within the last 30 days
- •Brain metastases in cancer history
- •Pregnant and nursing women
- •history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
- •inadequate respiratory function in option of investigator
研究者
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