Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catumaxomab (Removab)

Biological

Puncture free survival

Other names: Removab

Paracentesis

Procedure

Sponsors and collaborators

Lead sponsor

Neovii Biotech

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Feb 4, 2009
Registry last updated: Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed