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

Last updated: February 4, 2009
Sponsor: Neovii Biotech
Overall Status: Completed

Phase

2/3

Condition

Malignant Ascites

Liver Disease

Treatment

N/A

Clinical Study ID

NCT00836654
60117
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • histological confirmed diagnosis cancer

  • symptomatic malignant ascites

  • EpCAM positive tumor

  • EOCG 0-2

  • negative pregnancy

Exclusion

Exclusion Criteria:

  • acute or chronic infection

  • exposure to investigational product, cancer chemo- or radiotherapy within the last 28days

  • 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 cardiacarrhythmia within previous 3 months

  • inadequate respiratory function in option of investigator

Study Design

Total Participants: 258
Study Start date:
September 01, 2004
Estimated Completion Date:
November 30, 2006