CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers

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.

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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