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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR DACOMITINIB

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Clinical Trials for Dacomitinib

Trial ID Title Status Sponsor Phase Summary
NCT00818441 Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung Completed Pfizer Phase 2 This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
NCT01360554 ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer Completed Pfizer Phase 3 This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.
NCT01465802 Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO Completed Pfizer Phase 2 To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).
NCT01520870 Safety and Efficacy of PF-299804 (Dacomitinib), a Pan-HER Irreversible Inhibitor, in Patients With Recurrent Glioblastoma With EGFR Amplification or Presence of EGFRvIII Mutation. A Phase II CT. Active, not recruiting Pfizer Phase 2 This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene amplification and/or EGFRvIII mutation.
NCT01520870 Safety and Efficacy of PF-299804 (Dacomitinib), a Pan-HER Irreversible Inhibitor, in Patients With Recurrent Glioblastoma With EGFR Amplification or Presence of EGFRvIII Mutation. A Phase II CT. Active, not recruiting Grupo Español de Investigación en Neurooncología Phase 2 This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene amplification and/or EGFRvIII mutation.
NCT01571388 A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment Completed Pfizer Phase 1 The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dacomitinib

Condition Name

Condition Name for Dacomitinib
Intervention Trials
Healthy 2
Healthy Volunteers 2
Brain Tumor, Recurrent 1
Non-Small Cell Lung Cancer (NSCLC) 1
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Condition MeSH

Condition MeSH for Dacomitinib
Intervention Trials
Lung Neoplasms 5
Carcinoma, Non-Small-Cell Lung 5
Carcinoma, Squamous Cell 4
Carcinoma 3
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Clinical Trial Locations for Dacomitinib

Trials by Country

Trials by Country for Dacomitinib
Location Trials
United States 69
Japan 29
Spain 9
China 7
Korea, Republic of 6
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Trials by US State

Trials by US State for Dacomitinib
Location Trials
California 7
New York 4
Florida 4
Missouri 3
Colorado 3
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Clinical Trial Progress for Dacomitinib

Clinical Trial Phase

Clinical Trial Phase for Dacomitinib
Clinical Trial Phase Trials
Phase 3 2
Phase 2 9
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Dacomitinib
Clinical Trial Phase Trials
Completed 9
Recruiting 5
Active, not recruiting 3
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Clinical Trial Sponsors for Dacomitinib

Sponsor Name

Sponsor Name for Dacomitinib
Sponsor Trials
Pfizer 15
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 2
Grupo Español de Investigación en Neurooncología 1
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Sponsor Type

Sponsor Type for Dacomitinib
Sponsor Trials
Industry 16
Other 8
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