A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT01858389
Last Updated: 2017-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2013-07-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Cohort A
Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor.
Dacomitinib
Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.
Cohort B
Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.
Dacomitinib
Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.
Interventions
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Dacomitinib
Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.
Dacomitinib
Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.
Eligibility Criteria
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Inclusion Criteria
* Evidence of T790M mutation to enroll in Cohort A.
* Evidence of measurable disease by radiographic technique.
* Adequate organ function.
Exclusion Criteria
* Symptomatic brain metastases.
* Uncontrolled or significant cardiovascular disease.
* Pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Tower Hematology Oncology Medical Group
Beverly Hills, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Georgetown University Hospital-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Georgetown University Medical Center Department of Pharmacy, Research
Washington D.C., District of Columbia, United States
Memorial Sloan-Kettering Cancer Center-Rockefeller Outpatient Pavilion
New York, New York, United States
Investigational Drug Service, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center-Simmons Cancer Center Pharmacy
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UT Southwestern University Hospital - William P. Clements, Jr.
Dallas, Texas, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Tan W, Giri N, Quinn S, Wilner K, Parivar K. Evaluation of the potential effect of dacomitinib, an EGFR tyrosine kinase inhibitor, on ECG parameters in patients with advanced non-small cell lung cancer. Invest New Drugs. 2020 Jun;38(3):874-884. doi: 10.1007/s10637-019-00887-0. Epub 2019 Dec 19.
Yu HA, Ahn MJ, Cho BC, Gerber DE, Natale RB, Socinski MA, Giri N, Quinn S, Sbar E, Zhang H, Giaccone G. Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers. Lung Cancer. 2017 Oct;112:195-199. doi: 10.1016/j.lungcan.2017.08.017. Epub 2017 Aug 23.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A7471047
Identifier Type: -
Identifier Source: org_study_id