Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability
Principal Investigator
David Cunningham, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Royal Marsden Hospital, Sutton, UK
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
EMD 72000-024
NCT ID:
NCT00113581
Start Date:
October 2002
Completion Date:
January 2007
Related Keywords:
- Esophageal Cancer
- Gastric Cancer
- EMD 72000
- matuzumab
- Esophageal adenocarcinoma
- Gastric adenocarcinoma
- Adenocarcinoma
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms