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Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

NCT00464893 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-12-04

No results posted yet for this study

Summary

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.

Conditions

Interventions

DRUG

Catumaxomab

10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

DRUG

catumaxomab

10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg

Sponsors & Collaborators

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Carsten Bokemeyer, Prof MD · University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany

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
2007-04-30
Primary Completion
2009-04-30
Completion
2013-04-30

Countries

  • Austria
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00464893 on ClinicalTrials.gov