Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
研究概览
简要总结
This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated.
A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.
详细描述
Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with malignant ascites requiring therapeutic ascites puncture
- •Histological confirmed diagnosis of epithelial cancer
- •Patients where standard therapy is not available or no longer feasible
- •Karnofsky index ≥60 %
- •Life expectancy >12 weeks
排除标准
- •Concomitant treatment with other investigational product, chemo-, or radiotherapy
- •Recent exposure to an investigational product
- •Known or suspected hypersensitivity to catumaxomab or similar antibodies
- •Inadequate respiratory, renal or hepatic function
- •Inadequate blood count (platelets, neutrophils)
- •Required entirely parenteral nutrition
- •Patients with ileus or subileus within the last 30 days
- •Liver metastases with volume >70 % of liver tissue
- •Known portal vein obstruction
- •Known Brain metastases
- •Acute or chronic infection
- •Not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status
- •Albumin lower than 3 g/dL or total protein < 6g/dL
研究组 & 干预措施
A
Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab.
Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter.
干预措施: Catumaxomab (Drug)
A
Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab.
Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter.
干预措施: Prednisolone (Drug)
B
Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.
干预措施: Catumaxomab (Drug)
结局指标
主要结局
Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
时间窗: 6 months
Puncture-free survival defined as the time from clock start to first need for therapeutic ascites puncture or death, whichever occurs first.
时间窗: 6 months
次要结局
- immune monitoring(6 months)
- Safety measured by • Incidence of all AEs, • Changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis), • Physical examination, • Vital signs.(6 months)
- Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment(6 months)