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CompletedNCT00113581Updated Feb 19, 2014

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

A Phase 1 interventional study of EMD 72000 (matuzumab) + ECX in Esophageal Cancer and Gastric Cancer, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Esophageal Cancer
  • Gastric Cancer

Keywords

  • EMD 72000
  • matuzumab
  • Esophageal adenocarcinoma
  • Gastric adenocarcinoma
03

In context

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants

Interventions

  • DrugEMD 72000 (matuzumab) + ECX
06

What researchers measure

Primary outcomes

  1. Safety and tolerability

Secondary outcomes

  1. Pharmacodynamic parameters

  2. Pharmacokinetic parameters

  3. Response rate

07

Study locations

1 site
  • The Royal Marsden Hospital
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00113581
Lead sponsor
Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Jun 10, 2005
Start date
Oct 2002
Primary completion
May 2006
Completion
Jan 2007
Last update
Feb 19, 2014

Study contacts

David Cunningham, Professor
principal investigator · The Royal Marsden Hospital, Sutton, UK
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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