A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma

Merck KGaA, Darmstadt, Germany1 site in 1 country26 target enrollmentOctober 2002

ConditionsEsophageal Cancer Gastric Cancer

DrugsEMD 72000 (matuzumab) + ECX

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Esophageal Cancer
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 26
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).

In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

January 2007

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
•EGFR positive tumor
•KPS greater than 60
•Normal cardiac function
•Adequate liver and bone marrow function
•GFR greater than 60 ml/minute

Exclusion Criteria

•Previous chemotherapy
•Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
•Clinically significant ECG or cardiac history
•Radiotherapy or surgery within last 4 weeks