Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
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ClinicalTrials.gov Identifier: NCT00836654 |
Recruitment Status :
Completed
First Posted : February 4, 2009
Last Update Posted : February 5, 2009
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Sponsor:
Neovii Biotech
Information provided by:
Neovii Biotech
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast) Malignant Ascites | Biological: Catumaxomab (Removab) Procedure: paracentesis | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 258 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | November 2006 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1 Catumaxomab
Patient received Catumaxomab and paracentesis
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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
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Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00836654 History of Changes |
Other Study ID Numbers: |
60117 |
First Posted: | February 4, 2009 Key Record Dates |
Last Update Posted: | February 5, 2009 |
Last Verified: | February 2009 |
Keywords provided by Neovii Biotech:
EpCAM positive tumor malignant ascites intraperitoneal |
Additional relevant MeSH terms:
Ascites Pathologic Processes Catumaxomab Antibodies, Bispecific |
Gastrointestinal Agents Immunologic Factors Physiological Effects of Drugs |