PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

• Status: Completed
• Trial end date: 2012-06-11
• Target enrollment: 0
• Participant gender: All

Summary

To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Advanced Non-Small Cell Lung Cancer (NSCLC)

• Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.

• Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.

• Measurable disease .

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

• Tissue available for KRAS/ EGFR testing

• Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN

Exclusion Criteria:

• Chemotherapy

• Radiotherapy

• Biological or investigational agents within 4 weeks of baseline disease assessment.

• Patients who lack of tolerance of erlotinib therapy.