EUCTR2004-000723-15-GB进行中（未招募）不适用
Two-arm, randomized (2:1), open-label phase II/III study in EpCAM positive cancer patients with symptomatic malignant ascites using paracentesis plus the tri-functional antibody removab (anti-EpCAM x anti-CD3) versus paracentesis alone
Fresenius Biotech GmbH0 个研究点目标入组 340 人开始时间: 2005年3月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed and dated informed consent,
- •2.Histological confirmed diagnosis of cancer,
- •3.Patients with symptomatic malignant ascites requiring therapeutic ascites puncture. The ascites volume estimated by the radiologist must exceed 1 liter.
- •4.EpCAM positive tumor cells in the ascites fluid (only Population A),
- •5.Age: >/= 18 years,
- •6.Karnofsky Index >/=60
- •7.Negative pregnancy test at screening in women with childbearing potential,
- •8.Life expectancy >8 weeks,
- •9.At least 1 therapeutic ascites puncture within 5 weeks before screening puncture.
- •10.Patients who are refractory/resistant to chemotherapy or where the standard chemotherapy is no longer feasible
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Acute or chronic infections,
- •2.Exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C), before first infusion
- •3.Previous treatment with mouse or rat monoclonal antibodies,
- •4.Known or suspected hypersensitivity to removab or similar antibodies,
- •5.Inadequate renal function (Creatinine >1.5 x upper limit of normal [ULN]),
- •6.Inadequate hepatic function (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase >/= 5 x ULN; bilirubin >1.5 x ULN),
- •7.Platelets <80000 cells/qmm; absolute neutrophil count (ANC) <1500 cells/qmm,
- •8.Body mass index <17,
- •9.Patients with a reduced nutritional status requiring predominantly parenteral nutrition (>50% of energy intake),
- •10.Patients with gastric or small bowel feeding tube at study entry,
- •11.Patients with ileus within the last 30 days,
- •12.Patients with any other severe disease that would render a participation in the
- •study an undue risk,
- •13.Known brain metastases in cancer history,
- •14.Pregnant or nursing women or women with childbearing potential who are not using an effective contraceptive method during the study and at least 3 months after the last infusion,
- •15.History of myocardial infarction,
- •16.Signs or symptoms of relevant cardiovascular disease, congestive heart failure or cardiac arrhythmias (New York Heart Association [NYHA] class >II),
- •17.History of cerebrovascular accident,
- •18.Patients with portal vein obstruction or portal vein thrombosis diagnosed by CT-scan at screening,
- •19.Patients with extensive liver metastases (>70% of the liver is metastasized),
- •20.Inadequate respiratory function in the opinion of the investigator,
- •21.Any further condition which according to the investigator results in an undue risk of the patient by participating in the present study.
研究者
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