Clinical Trial: Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Open Label Study to Evaluate the Safety of a Second I.P. Infusion Cycle of Catumaxomab in Patients With Malignant Ascites Due to Carcinoma, Requiring Their First
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 Summary: 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).
Sponsor: Neovii Biotech
Current Primary Outcome: proportion of patients who are able to receive a second cycle of catumaxomab [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- puncture free survival [ Time Frame: 1-3 months ]
- incidence and severity of adverse events [ Time Frame: 1 month ]
- Quality of Life [ Time Frame: 1 month ]
- Development of human-anti-mouse antibodies [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Neovii Biotech
Dates:
Date Received: January 13, 2010
Date Started: November 2009
Date Completion:
Last Updated: October 2, 2012
Last Verified: August 2012
