EUCTR2006-004484-54-DE进行中（未招募）不适用
Multicenter, single-arm, phase II study of the tri functional antibody catumaxomab (anti EpCAM x anti-CD3) administered intra- and postoperatively in patients with epithelial ovarian cancer - n.a.
Fresenius Biotech GmbH0 个研究点开始时间: 2007年5月22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
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
- Female
入选标准
- •1.Signed and dated informed consent form before any protocol-specific screening
- •2.Patient has a primary diagnosis of an epithelial ovarian cancer including clear cell
- •carcinoma (FIGO IA(G2-G3) – IV) (histologically confirmed)
- •3.Karnofsky index > = 70
- •4.Female at an age of 18 years or older
- •5.Negative pregnancy test result at screening in women of childbearing potential
- •(applies to patients without documented menopause or sterility)
- •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.Exposure to prior cancer therapy (surgery, investigational product-, chemo- or
- •radio-therapy) specific for ovarian cancer
- •2.Previous treatment with non-humanized mouse or rat monoclonal antibodies
- •3.Known/suspected hypersensitivity to catumaxomab or similar antibodies
- •4.Second malignancy within the last 5 years (if directly influencing patient's overall
- •5.Presence of constant immunosuppressive therapy
- •6.Presence of symptomatic heart failure or occlusive arterial diseases
- •7.Inadequate renal function (creatinine >1.5 x ULN)
- •8.Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin = 1.5 x ULN)
- •9.Platelets <100.000 cells/mm3; absolute neutrophil count <1500 cells/mm3
- •10.Presence of any acute or chronic systemic infection
- •11.Presence of complete bowel obstruction
- •12.Presence of symptomatic brain metastases
- •13.Inadequate respiratory function in the opinion of the investigator
- •14.Any further condition which, according to the opinion of the investigator, results
- •in an undue risk of the patient by participating in the present study
- •15.Parallel participation in another clinical trial or previous participation in this study
- •16.Pregnant or nursing women, or women with childbearing potential who are not
- •using an effective contraceptive method during the study and for at least 3
- •months after the last infusion
研究者
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