Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
2 other identifiers
interventional
119
5 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2009
CompletedStudy Start
First participant enrolled
March 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2015
CompletedResults Posted
Study results publicly available
June 1, 2016
CompletedJanuary 8, 2019
December 1, 2018
3.1 years
January 5, 2009
April 25, 2016
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) at Month 4: Cohort A
PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (\>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
Baseline up to Month 4
Secondary Outcomes (8)
Progression-Free Survival (PFS) at Month 4: Cohort B
Baseline up to Month 4
Progression-Free Survival (PFS)
Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Best Overall Response (BOR)
Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Duration of Response (DR)
Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
Overall Survival (OS)
Randomization until death or last date known to be alive.
- +3 more secondary outcomes
Study Arms (2)
Cohort A
EXPERIMENTALDacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Cohort B
EXPERIMENTALDacomitinib in patients with HER2 mutated or amplified NSCLC
Interventions
Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
Eligibility Criteria
You may qualify if:
- Advanced adenocarcinoma of lung, measurable disease
- Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
- patients with known EGFR activating mutation regardless of smoking status
- ECOG(Eastern Cooperative Oncology Group) 0-1.
- Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
You may not qualify if:
- Active brain metastases
- Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
- known EGFR wild type NSCLC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (41)
University of California, Irvine
Orange, California, 92868-3298, United States
Chao Family Comprehensive Cancer Center UC Irvine Medical Center
Orange, California, 92868, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523, United States
Pacific Cancer Care
Salinas, California, 93901, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
University of Colorado Clinical Trials Office (CTO)
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Florida Cancer Specialists
Fort Myers, Florida, 33919, United States
National Institutes of Health National Cancer Institute
Bethesda, Maryland, 20892, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02210, United States
Dana-Farber Cancer lnstitute
Boston, Massachusetts, 02210, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
St. John's Hospital,
Springfield, Missouri, 65804, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022, United States
Stony Brook University Medical Center - Cancer Center
Stony Brook, New York, 11794-9446, United States
Investigational Drug Service, Pharmacy Department, UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
Division of Hemotology/Oncology
Chapel Hill, North Carolina, 27599-2008, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600, United States
Morris Cancer Center
Durham, North Carolina, 27710, United States
Legacy Pharma Research
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, P.C
Bismarck, North Dakota, 58501, United States
Chattanooga Oncology & Hematology Associates, P.C.
Chattanooga, Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203 (Administration), United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203(Pharmacy), United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Department of Clinical Oncology, Tuen Mun Hospital
Tuenmen, NEW Territories, 0, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Tuenmen, NEW Territories, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
New Territories, Hong Kong
Prince of Wales Hospital
Shatin, NT, Hong Kong
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
Aichi cancer center central hospital Thoracic Oncology
Aichi, 464-8681, Japan
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
Seoul, 120-752, South Korea
SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
Seoul, 135-710, South Korea
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (2)
Kris MG, Camidge DR, Giaccone G, Hida T, Li BT, O'Connell J, Taylor I, Zhang H, Arcila ME, Goldberg Z, Janne PA. Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors. Ann Oncol. 2015 Jul;26(7):1421-7. doi: 10.1093/annonc/mdv186. Epub 2015 Apr 21.
PMID: 25899785DERIVEDJanne PA, Ou SI, Kim DW, Oxnard GR, Martins R, Kris MG, Dunphy F, Nishio M, O'Connell J, Paweletz C, Taylor I, Zhang H, Goldberg Z, Mok T. Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: a multicentre, open-label, phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1433-1441. doi: 10.1016/S1470-2045(14)70461-9. Epub 2014 Nov 5.
PMID: 25456362DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Results have been included for Cohort B and updated for Cohort A since the Primary completion date.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 7, 2009
Study Start
March 11, 2009
Primary Completion
April 27, 2012
Study Completion
April 30, 2015
Last Updated
January 8, 2019
Results First Posted
June 1, 2016
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.