At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
catumaxomabdrug
Likely dose
catumaxomab 10 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
In Brief
A Phase 2 clinical trial evaluating catumaxomab for Malignant Ascites. Completed, enrolled 32 participants across 18 sites.
Detailed Summary
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Ascites
CountriesUnited States
CollaboratorsFresenius Biotech North America
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2006
Enrollment StartJun 2006
Primary CompletionDec 2009
Study CompletionAug 2010
TodayJul 2026
First PostedMay 17, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.1 years ago
Interventions
catumaxomabdrug
Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).