NCT01449201

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

Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head Neck Cancer Squamous Cell Metastatic
• Head Neck Cancer Squamous Cell Recurrent

Interventions

Type	Name	Description
DRUG	PF-00299804	45 mg P.O. Daily (28-day treatment as one treatment cycle)

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-10-01
• Completion: 2014-03-01
• First posted: 2011-10-10
• Last updated: 2014-09-30

Locations

6 sites across 1 country: South Korea