NCT01065246已完成2 期
Phase II Open Label Study to Evaluate the Safety of a Second I.P. Infusion Cycle of Catumaxomab in Patients With Malignant Ascites Due to Carcinoma, Requiring Their First Therapeutic Puncture After Treatment in the CASIMAS Study
Neovii Biotech1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- proportion of patients who are able to receive a second cycle of catumaxomab
研究概览
简要总结
This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.
详细描述
Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).
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
- •patients who have completed 4 infusions of catumaxomab in the CASIMAS study
- •age >= 18 years
- •Karnofsky index >= 60 %
- •patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60days following last catumaxomab infusion in the CASIMAS study
- •Patients where standard therapy is either not available or no longer feasible
排除标准
- •acute or chronic infection
- •concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy
- •previous treatment with entirely murine monoclonal antibodies other than catumaxomab
- •liver metastases with volume >70 % of liver metastasized tissue
研究组 & 干预措施
catumaxomab
Experimental
干预措施: catumaxomab (Drug)
结局指标
主要结局
proportion of patients who are able to receive a second cycle of catumaxomab
时间窗: 1 month
次要结局
- puncture free survival(1-3 months)
- incidence and severity of adverse events(1 month)
- Quality of Life(1 month)
- Development of human-anti-mouse antibodies(1 month)
研究者
研究点 (1)
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