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

Merck KGaA, Darmstadt, Germany26 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer Gastric Cancer

Interventions

EMD 72000 (matuzumab) + ECXDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Royal Marsden Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability

Secondary Outcomes

Pharmacodynamic parameters

Pharmacokinetic parameters

Response rate

Data from ClinicalTrials.gov

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