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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib; Mitogens

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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