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
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
Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
Florian Lordick, PD Dr. med.
Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig