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Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites (SECIMAS)

N

Neovii Biotech

Status and phase

Completed
Phase 2

Conditions

Malignant Ascites Due to Epithelial Carcinoma

Treatments

Drug: catumaxomab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01065246
IP-CAT-AC-04
2009-014076-22 (EudraCT Number)

Details and patient eligibility

About

This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.

Full description

Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who have completed 4 infusions of catumaxomab in the CASIMAS study
  • age >= 18 years
  • Karnofsky index >= 60 %
  • patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60days following last catumaxomab infusion in the CASIMAS study
  • Patients where standard therapy is either not available or no longer feasible

Exclusion criteria

  • acute or chronic infection
  • concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy
  • previous treatment with entirely murine monoclonal antibodies other than catumaxomab
  • liver metastases with volume >70 % of liver metastasized tissue

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

catumaxomab
Experimental group
Treatment:
Drug: catumaxomab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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