Back to resultsDacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
Primary Purpose
Carcinoma, Non-small Cell
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-small Cell focused on measuring lung cancer adenocarcinoma HER2
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
Sites / Locations
- University of California, Irvine
- Chao Family Comprehensive Cancer Center UC Irvine Medical Center
- Bay Area Cancer Research Group, LLC
- Pacific Cancer Care
- San Francisco General Hospital
- University of Colorado Clinical Trials Office (CTO)
- University of Colorado Hospital
- Florida Cancer Specialists
- National Institutes of Health National Cancer Institute
- Massachusetts General Hospital
- Brigham & Women's Hospital
- Dana-Farber Cancer Institute
- Dana-Farber Cancer Institute
- Dana-Farber Cancer lnstitute
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- St. John's Hospital,
- Memorial Sloan-Kettering Cancer Center
- Stony Brook University Medical Center - Cancer Center
- Investigational Drug Service, Pharmacy Department, UNC Hospitals
- Division of Hemotology/Oncology
- UNC Hospitals, The University of North Carolina at Chapel Hill
- Morris Cancer Center
- Legacy Pharma Research
- Mid Dakota Clinic, P.C
- Chattanooga Oncology & Hematology Associates, P.C.
- Sarah Cannon Research Institute
- Sarah Cannon Research Institute
- Virginia Cancer Institute
- Seattle Cancer Care Alliance
- University of Washington Medical Center
- Department of Clinical Oncology, Tuen Mun Hospital
- Department of Clinical Oncology, Tuen Mun Hospital
- Department of Clinical Oncology, Tuen Mun Hospital
- Prince of Wales Hospital
- The Cancer Institute Hospital of JFCR
- Aichi cancer center central hospital Thoracic Oncology
- Seoul National University Hospital
- Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
- SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Arm Description
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression-Free Survival (PFS) at Month 4: Cohort B
PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as 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 RECIST v1.0 criteria. PD: >=20% 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.
Progression-Free Survival (PFS)
PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% 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. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.
Best Overall Response (BOR)
BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.
Duration of Response (DR)
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.
Overall Survival (OS)
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.
Trough Plasma Concentrations (Ctrough) of Dacomitinib
Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00818441
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 11, 2009 (Actual)
Primary Completion Date
April 27, 2012 (Actual)
Study Completion Date
April 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-small Cell
Keywords
lung cancer adenocarcinoma HER2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Intervention Type
Drug
Intervention Name(s)
Dacomitinib (PF-00299804)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Dacomitinib (PF-00299804)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) at Month 4: Cohort A
Description
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.
Time Frame
Baseline up to Month 4
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) at Month 4: Cohort B
Description
PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as 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 RECIST v1.0 criteria. PD: >=20% 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.
Time Frame
Baseline up to Month 4
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% 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. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.
Time Frame
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.
Title
Best Overall Response (BOR)
Description
BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.
Time Frame
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.
Title
Duration of Response (DR)
Description
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.
Time Frame
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.
Title
Overall Survival (OS)
Description
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame
Randomization until death or last date known to be alive.
Title
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Description
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.
Time Frame
Baseline (Cycle [C]1 Day 1), up to C75
Title
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
Description
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.
Time Frame
Baseline (C1D1) up to C75
Title
Trough Plasma Concentrations (Ctrough) of Dacomitinib
Description
Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).
Time Frame
Predose on C1D14, C2D1, C3D1, C4D1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868-3298
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Pacific Cancer Care
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of Colorado Clinical Trials Office (CTO)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
National Institutes of Health National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Dana-Farber Cancer lnstitute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. John's Hospital,
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Stony Brook University Medical Center - Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9446
Country
United States
Facility Name
Investigational Drug Service, Pharmacy Department, UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Division of Hemotology/Oncology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-2008
Country
United States
Facility Name
UNC Hospitals, The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Morris Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Legacy Pharma Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic, P.C
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Chattanooga Oncology & Hematology Associates, P.C.
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203 (Administration)
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203(Pharmacy)
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Department of Clinical Oncology, Tuen Mun Hospital
City
Tuen Mun
State/Province
NEW Territories
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Department of Clinical Oncology, Tuen Mun Hospital
City
Tuen Mun
State/Province
NEW Territories
Country
Hong Kong
Facility Name
Department of Clinical Oncology, Tuen Mun Hospital
City
New Territories
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin, NT
Country
Hong Kong
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Aichi cancer center central hospital Thoracic Oncology
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
25899785
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.
Results Reference
derived
PubMed Identifier
25456362
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471017&StudyName=Dacomitinib%20%28PF-00299804%29%20As%20A%20Single%20Oral%20Agent%20In%20Selected%20Patients%20With%20Adenocarcinoma%20Of%20The%20Lung%20%0A%20
Description
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Learn more about this trial
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
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