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

NCT01065246 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Ascites Due to Epithelial Carcinoma

Interventions

DRUG

catumaxomab

4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab

Sponsors & Collaborators

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Jalid Sehouli, MD, Prof · Charité Campus Virchow Clinic Berlin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-30
Completion
2011-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065246 on ClinicalTrials.gov