CLINICAL TRIALS PROFILE FOR DACOMITINIB

All Clinical Trials for DACOMITINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00818441 ↗	Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung	Completed	Pfizer	Phase 2	2009-03-11	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	2011-06-16	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	2011-12-26	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.	Completed	Pfizer	Phase 2	2012-02-01	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.	Completed	Grupo Español de Investigación en Neurooncología	Phase 2	2012-02-01	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.

Clinical Trial Conditions for DACOMITINIB

Condition Name

Condition Name for DACOMITINIB
Intervention	Trials
Non-small Cell Lung Cancer	3
Non Small Cell Lung Cancer	2
EGFR Positive Non-small Cell Lung Cancer	2
Non-Small Cell Lung Cancer (NSCLC)	2

Condition MeSH

Condition MeSH for DACOMITINIB
Intervention	Trials
Lung Neoplasms	15
Carcinoma, Non-Small-Cell Lung	13
Carcinoma, Squamous Cell	5
Brain Neoplasms	5

Clinical Trial Locations for DACOMITINIB

Trials by Country

Trials by Country for DACOMITINIB
Location	Trials
United States	76
Japan	30
Italy	22
India	10
Spain	9

Trials by US State

Trials by US State for DACOMITINIB
Location	Trials
California	7
New York	6
Florida	5
New Jersey	4
Washington	3

Clinical Trial Progress for DACOMITINIB

Clinical Trial Phase

Clinical Trial Phase for DACOMITINIB
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	19

Clinical Trial Status

Clinical Trial Status for DACOMITINIB
Clinical Trial Phase	Trials
Completed	14
Recruiting	8
Not yet recruiting	5

Clinical Trial Sponsors for DACOMITINIB

Sponsor Name

Sponsor Name for DACOMITINIB
Sponsor	Trials
Pfizer	20
National Cancer Centre, Singapore	2
The Netherlands Cancer Institute	2

Sponsor Type

Sponsor Type for DACOMITINIB
Sponsor	Trials
Industry	35
Other	27