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

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