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A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Principal Investigator

David Cunningham, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Royal Marsden Hospital, Sutton, UK

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

EMD 72000-024

NCT ID:

NCT00113581

Start Date:

October 2002

Completion Date:

January 2007

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • EMD 72000
  • matuzumab
  • Esophageal adenocarcinoma
  • Gastric adenocarcinoma
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

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