A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

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

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).

• Evidence of T790M mutation to enroll in Cohort A.

• Evidence of measurable disease by radiographic technique.

• Adequate organ function.

Exclusion Criteria:

• Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.

• Symptomatic brain metastases.

• Uncontrolled or significant cardiovascular disease.

• Pregnant or breastfeeding.