Cancer Clinical Trial
Official title:
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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