Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy
Sponsor study identifier
interventional
49
1 country
6
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
March 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 4, 2011
Actual (reported)October 10, 2011
Actual (reported)October 2013
Actual (reported)March 2014
Actual (reported)Response rate
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
every 8 weeks
Best objective response
every 8 weeks
Progression-free survival
every 8 weeks
Overall survival
every 12 weeks
Toxicity profile
every 4 weeks
45 mg P.O. Daily (28-day treatment as one treatment cycle)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Severance Hospital
Seoul, Seoul, 120-752, South Korea
Chilgok Kyungpook National University Hospital
Daegu, South Korea
Dongsan Medical Center
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital Cancer Center
Seoul, South Korea
Byoung Chul Cho, M.D.,Ph.D.
Yonsei University
49 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2011
First Posted
October 10, 2011
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Contact the study team to confirm eligibility.
Primary Completion
October 2013
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
September 30, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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