EUCTR2006-005704-13-GB进行中（未招募）1 期
A Phase II Study of Intravenous CNTO328 in Patients with Recurrent Epithelial Ovarian Cancer - CNTO328 in ovarian cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Women with recurrent histologically confirmed ovarian carcinoma, Fallopian tube carcinoma, or primary peritoneal carcinoma of serous, endometrioid or clear cell sub-types.
- •Previous treatment with no more than three platinum-containing chemotherapy regimes.
- •Patients are also eligible if they have relapsed within six months of completing first line platinum-containing chemotherapy or have experienced documented progression whilst receiving first-line platinum-containing chemotherapy
- •Life expectancy of at least 3 months
- •Age = 18 years
- •WHO performance status of 0, 1 or 2
- •Patients must have the following clinical laboratory values:
- •Granulocyte count > 1.0 x 109/l
- •Platelet count > 100 x 109/l
- •Hb > 9.0 g/dl
- •Serum creatinine < 1.5 x Upper Limit of Normal (ULN)
- •Bilirubin < 30 µmol/l
- •Albumin > 30 g/dl
- •Prothrombin and activated partial thromboplastin times < 1.5 x ULN
- •Alk Phos < 5 x ULN
- •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
- •Tumours of malignant mixed mesodermal (MMMT) or mucinous types.
- •Unresolved bowel obstruction
- •Prior administration of or hypersensitivity to humanised monoclonal antibodies
- •Chemotherapy within the preceding 3 weeks
- •Radiotherapy within the preceding 3 weeks
- •Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
- •Known leptomeningeal involvement
- •Pregnant or lactating females.
- •Inability or unwillingness to give informed consent.
- •Ongoing active infection or a documented history of HIV infection, Hepatitis B or C.
- •Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease (Appendix 7).
- •Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease.
- •No corticosteroids to be taken within the preceding 4 weeks
研究者
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