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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non Small Cell Lung

Treatments: Drug: PF-00299804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548093

A7471002

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

66 participants in 2 patient groups

1

Experimental group

Description:

descriptive: adenocarcinoma histology

Treatment:

Drug: PF-00299804

Drug: PF-00299804

2

Experimental group

Description:

descriptive: non-adenocarcinoma histology

Treatment:

Drug: PF-00299804

Drug: PF-00299804