ClinicalTrials.Veeva

Menu

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

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 1

Conditions

Gastric Cancer
Esophageal Cancer

Treatments

Drug: EMD 72000 (matuzumab) + ECX

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113581
EMD 72000-024

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems