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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant Ascites

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

60117

NCT ID:

NCT00836654

Start Date:

September 2004

Completion Date:

November 2006

Related Keywords:

  • EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast)
  • Malignant Ascites
  • EpCAM positive tumor
  • malignant ascites
  • intraperitoneal
  • Ascites

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