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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00836654

Enrollment

258

Registered

2009-02-04

Start date

2004-09-30

Completion date

2006-11-30

Last updated

2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

EpCAM positive tumor, malignant ascites, intraperitoneal

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.

Interventions

BIOLOGICALCatumaxomab (Removab)

Puncture free survival

PROCEDUREparacentesis

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026