NCT00113581

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

3.6 years

First QC Date

June 9, 2005

Last Update Submit

February 17, 2014

Conditions

Esophageal CancerGastric Cancer

Keywords

EMD 72000matuzumabEsophageal adenocarcinomaGastric adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

Secondary Outcomes (3)

  • Pharmacodynamic parameters

  • Pharmacokinetic parameters

  • Response rate

Interventions

EMD 72000 (matuzumab) + ECXDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

matuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • David Cunningham, Professor

    The Royal Marsden Hospital, Sutton, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

October 1, 2002

Primary Completion

May 1, 2006

Study Completion

January 1, 2007

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

GB(1)