drugset / Trial / NCT01449201

PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma

NCT01449201

Phase 2 Completed 49 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.

Timeline

Start
2011-10
Primary completion
2013-10
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject DACOMITINIB ANHYDROUS Small molecule 45 mg Oral