Status:
COMPLETED
Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
Lead Sponsor:
Neovii Biotech
Conditions:
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast)
Malignant Ascites
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- histological confirmed diagnosis cancer
- symptomatic malignant ascites
- EpCAM positive tumor
- EOCG 0-2
- negative pregnancy
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00836654
Start Date
September 1 2004
End Date
November 1 2006
Last Update
February 5 2009
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