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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00113581
Other study ID # EMD 72000-024
Secondary ID
Status Completed
Phase Phase 1
First received June 9, 2005
Last updated February 17, 2014
Start date October 2002
Est. completion date January 2007

Study information

Verified date February 2014
Source Merck KGaA
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 2007
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
EMD 72000 (matuzumab) + ECX


Locations

Country Name City State
United Kingdom The Royal Marsden Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Merck KGaA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability
Secondary Pharmacodynamic parameters
Secondary Pharmacokinetic parameters
Secondary Response rate
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