Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer

Phase 1

Completed

• Conditions: Esophageal Cancer; Gastric Cancer

• Registration Number: NCT00113581
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-06-09
• Study First Submitted QC: 2005-06-09
• Study First Posted: 2005-06-10
• Primary Completion: 2006-05
• Study Completion: 2007-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Response rate
Pharmacodynamic parameters
Pharmacokinetic parameters

Trial Locations

Locations (1)

The Royal Marsden Hospital; 🇬🇧 London, United Kingdom