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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113581

Enrollment

Registered

2005-06-10

Start date

2002-10-31

Completion date

2007-01-31

Last updated

2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Gastric Cancer

Keywords

EMD 72000, matuzumab, Esophageal adenocarcinoma, Gastric adenocarcinoma

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).

Interventions

DRUGEMD 72000 (matuzumab) + ECX

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
Pharmacodynamic parameters	—
Pharmacokinetic parameters	—
Response rate	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026