Clinical trial NCT00818441: Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
Official title: A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-small Cell
Keywords: lung cancer adenocarcinoma HER2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-Free Survival (PFS) at Month 4: Cohort A
timeFrame: Baseline up to Month 4
Secondary outcomes:
measure: Progression-Free Survival (PFS) at Month 4: Cohort B
timeFrame: Baseline up to Month 4
measure: Progression-Free Survival (PFS)
timeFrame: 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.
measure: Best Overall Response (BOR)
timeFrame: 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.
measure: Duration of Response (DR)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: Randomization until death or last date known to be alive.
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
timeFrame: Baseline (Cycle [C]1 Day 1), up to C75
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
timeFrame: Baseline (C1D1) up to C75
measure: Trough Plasma Concentrations (Ctrough) of Dacomitinib
timeFrame: Predose on C1D14, C2D1, C3D1, C4D1
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center UC Irvine Medical Center
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Salinas
country: United States
facility: Pacific Cancer Care
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado Clinical Trials Office (CTO)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Bethesda
country: United States
facility: National Institutes of Health National Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer lnstitute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Springfield
country: United States
facility: St. John's Hospital,
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center - Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: Investigational Drug Service, Pharmacy Department, UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: Division of Hemotology/Oncology
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals, The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Morris Cancer Center
state: North Carolina
city: Bismarck
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Bismarck
country: United States
facility: Mid Dakota Clinic, P.C
state: North Dakota
city: Chattanooga
country: United States
facility: Chattanooga Oncology & Hematology Associates, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Tuen Mun
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital
state: NEW Territories
city: Tuen Mun
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital
state: NEW Territories
city: New Territories
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital
city: Shatin, NT
country: Hong Kong
facility: Prince of Wales Hospital
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Aichi
country: Japan
facility: Aichi cancer center central hospital Thoracic Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
city: Seoul
country: Korea, Republic of
facility: SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Janne 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.