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

Phase 2

Completed

• Conditions: Malignant Ascites Due to Epithelial Carcinoma
• Interventions: Drug: catumaxomab

• Registration Number: NCT01065246
• Lead Sponsor: Neovii Biotech

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2011-04
• Study Completion: 2011-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• patients who have completed 4 infusions of catumaxomab in the CASIMAS study
• age >= 18 years
• Karnofsky index >= 60 %
• patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60days following last catumaxomab infusion in the CASIMAS study
• Patients where standard therapy is either not available or no longer feasible

Exclusion Criteria

• acute or chronic infection
• concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy
• previous treatment with entirely murine monoclonal antibodies other than catumaxomab
• liver metastases with volume >70 % of liver metastasized tissue

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
catumaxomab	catumaxomab	-

Primary Outcome Measures

Name	Time	Method
proportion of patients who are able to receive a second cycle of catumaxomab	1 month

Secondary Outcome Measures

Name	Time	Method
puncture free survival	1-3 months
incidence and severity of adverse events	1 month
Quality of Life	1 month
Development of human-anti-mouse antibodies	1 month

Trial Locations

Locations (1)

Charité Campus Virchow Clinic; 🇩🇪 Berlin, Germany