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Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites

NCT00326885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-10-17

Study results available
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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.

Conditions

  • Malignant Ascites

Interventions

DRUG

catumaxomab

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).

Sponsors & Collaborators

  • Fresenius Biotech North America

    collaborator INDUSTRY

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Jonathan Berek, MD MMSc · Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-12-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00326885 on ClinicalTrials.gov