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Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

NCT00836654 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2009-02-05

No results posted yet for this study

Summary

The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.

Conditions

  • EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast)
  • Malignant Ascites

Interventions

BIOLOGICAL

Catumaxomab (Removab)

Puncture free survival

PROCEDURE

paracentesis

Sponsors & Collaborators

  • Neovii Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-11-30
Completion
2006-11-30

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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 NCT00836654 on ClinicalTrials.gov