Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818441
First received: January 5, 2009
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-small Cell
Drug: Dacomitinib (PF-00299804)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Trial Of Dacomitinib (Pf-00299804) In Selected Patients With Advanced Adenocarcinoma Of The Lung

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort A] PFS is defined as the interval from enrollment to date of objective progression or death due to any cause. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort B] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact.

  • --Duration of Response (DR) per cohort [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) per cohort [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) per cohort [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall safety profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Lung Cancer module (LC13)

  • Trough concentrations of PF-00299804 in blood after repeated dosing [ Time Frame: 10months ] [ Designated as safety issue: No ]
  • Best Overall Response (BOR) per RECIST per cohort [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: March 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Drug: Dacomitinib (PF-00299804)
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).
Experimental: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Drug: Dacomitinib (PF-00299804)
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818441

  Hide Study Locations
Locations
United States, California
Chao Family Comprehensive Cancer Center UC Irvine Medical Center
Orange, California, United States, 92868
UCI Medical Center
Orange, California, United States, 92868
University of California, Irvine
Orange, California, United States, 92868
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States, 94523
Los Palos Oncology Hematology
Salinas, California, United States, 93901
San Francisco General Hospital
San Francisco, California, United States, 94110
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33619
United States, Georgia
Chattanooga Oncology & Hematology Associates, P.C.
Ringgold, Georgia, United States, 30736
United States, Maryland
National Institutes of Health National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
St. John's Medical Research Institute, Inc.
Springfield, Missouri, United States, 65807
United States, New York
MSKCC- PIs Location
New York, New York, United States, 10065
Stony Brook University Medical Center - Cancer Center
Stony Brook, New York, United States, 11794-9446
United States, North Carolina
Investigation Drug Service
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599-7600
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, North Dakota
Mid Dakota Clinic, P.C
Bismarck, North Dakota, United States, 58501
Legacy Pharma Research
Bismarck, North Dakota, United States, 58501
United States, Tennessee
Chattanooga Oncology & Hematology Associates, P.C.
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Research Institute- Chattanooga Oncology & Hematology Associates- Memorial Plaza
Chattanooga, Tennessee, United States, 37404-1130
Chattanooga Oncology & Hematology Associates, P.C.
Hixson, Tennessee, United States, 37343
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Seattle Cancer Care Allian
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Tuen Mun, New Territories, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Tuen Mun, New Territories, Hong Kong, 0
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin,, NT, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
New Territories, Hong Kong
Japan
Aichi cancer center central hospital Thoracic Oncology
Aichi, Japan, 464-8681
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Korea, Republic of
SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital, Department of Interanl Medicine
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
Seoul, Korea, Republic of, 120-752
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10018
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00818441     History of Changes
Other Study ID Numbers: A7471017, 2011-002794-39
Study First Received: January 5, 2009
Last Updated: May 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
lung cancer adenocarcinoma HER2

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on June 30, 2015