Status:

COMPLETED

First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Lead Sponsor:

AstraZeneca

Conditions:

Pulmonary Cancer

Eligibility:

All Genders

19+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Eligibility Criteria

Inclusion

  • Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
  • WHO Performance Status 0-2
  • No prior chemotherapy, biological or immunological therapy/surgery

Exclusion

  • Any evidence of clinically active interstitial lung disease
  • Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
  • Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00344773

Start Date

March 1 2006

End Date

December 1 2007

Last Update

June 29 2010

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Research Site

Seongnam-si, South Korea

2

Research Site

Seoul, South Korea