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

This study has been completed.
Sponsor:
Information provided by:
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT00836654
First received: February 3, 2009
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast)
Malignant Ascites
Biological: Catumaxomab (Removab)
Procedure: paracentesis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Neovii Biotech:

Enrollment: 258
Study Start Date: September 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Catumaxomab
Patient received Catumaxomab and paracentesis
Biological: Catumaxomab (Removab)
Puncture free survival
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00836654     History of Changes
Other Study ID Numbers: 60117
Study First Received: February 3, 2009
Last Updated: February 4, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Neovii Biotech:
EpCAM positive tumor
malignant ascites
intraperitoneal

Additional relevant MeSH terms:
Ascites
Pathologic Processes
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014