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

Neovii Biotech

Status and phase

Completed

Phase 3

Phase 2

Conditions

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

Malignant Ascites

Treatments

Biological: Catumaxomab (Removab)

Procedure: paracentesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00836654

60117

Details and patient eligibility

About

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.

Enrollment

258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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