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

Phase 2

Completed

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

• Registration Number: NCT00836654
• Lead Sponsor: Neovii Biotech

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2009-02
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Last Update Submitted: 2009-02-04
• Last Update Posted: 2009-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER