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

February 4, 2009 updated by: Neovii Biotech

Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histological confirmed diagnosis cancer
  • symptomatic malignant ascites
  • EpCAM positive tumor
  • EOCG 0-2
  • negative pregnancy

Exclusion Criteria:

  • acute or chronic infection
  • exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
  • previous treatment with mouse monoclonal antibodies
  • known or suspected hypersensitivity to Removab or similar antibodies
  • inadequate renal function
  • inadequate hepatic function (AST, ALt, GTP,< x ULN; bilirubin <1.5xULN)
  • Platelets > 80000 cells/mm3; absolute neutrophil count (ANC) < 1500 cells/mm3
  • BMI < 17
  • Patients with reduced nutritional status
  • Ileus within the last 30 days
  • Brain metastases in cancer history
  • Pregnant and nursing women
  • history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
  • inadequate respiratory function in option of investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Catumaxomab
Patient received Catumaxomab and paracentesis
Biological: Catumaxomab (Removab)
Puncture free survival
Other Names:
  • Removab
Procedure: paracentesis
No Intervention: 2:
Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovii Biotech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

February 5, 2009

Last Update Submitted That Met QC Criteria

February 4, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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