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Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites

2014-08-27 03:16:02 | BioPortfolio

Summary

This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.

Description

Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Ascites Due to Epithelial Carcinoma

Intervention

catumaxomab

Location

Charité Campus Virchow Clinic
Berlin
Germany
13353

Status

Recruiting

Source

Fresenius Biotech GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:02-0400

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