A study to investigate the safety of a second treatment cycle with catumaxomab given as 3 hour infusions in patients who are suffering from malignant ascites due to epithelial tumor cells. Patients who already completed the Casimas study receiving 4 ascending i.p. infusions of catumaxomab and requiring their first therapeutic puncture after at least 60 days following last catumaxomab i.p. infusion in the CASIMAS study will be enrolled in this study.

Registry ID

EUCTR2009-014076-22

Source registry

EUCTR

Status

Completed

Phase

PHASE2

Sponsor

Fresenius Biotech GmbH

Start date

2009-09-23

Completion date

2011-05-10

Last update

2026-08-16

Conditions

• Malignant Ascites
• malignant ascites / ascitis maligna
• patients with malignant ascites due to carcinoma

Summary

The primary objective of the study is to evaluate the safety of a second 3 hour i.p. infusion cycle, consisting of four ascending dosages of catumaxomab after completing four i.p. infusions in the CASIMAS study, in patients with malignant ascites due to carcinoma requiring their first therapeutic puncture.

Locations

• , , France
• , , Germany
• , , Sweden
• , , Belgium
• , , Spain
• , , Italy

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