- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818441
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
December 19, 2018 updated by: Pfizer
A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Territories, Hong Kong
- Department of Clinical Oncology, Tuen Mun Hospital
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Shatin, NT, Hong Kong
- Prince of Wales Hospital
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NEW Territories
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Tuen Mun, NEW Territories, Hong Kong
- Department of Clinical Oncology, Tuen Mun Hospital
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Tuen Mun, NEW Territories, Hong Kong
- Department of Clinical Oncology, Tuen Mun Hospital
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Aichi, Japan, 464-8681
- Aichi cancer center central hospital Thoracic Oncology
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Tokyo
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Koto-Ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Seoul, Korea, Republic of, 120-752
- Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
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Seoul, Korea, Republic of, 135-710
- SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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California
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Orange, California, United States, 92868-3298
- University of California, Irvine
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center UC Irvine Medical Center
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Pleasant Hill, California, United States, 94523
- Bay Area Cancer Research Group, LLC
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Salinas, California, United States, 93901
- Pacific Cancer Care
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San Francisco, California, United States, 94110
- San Francisco General Hospital
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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Aurora, Colorado, United States, 80045
- University of Colorado Clinical Trials Office (CTO)
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Florida
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Fort Myers, Florida, United States, 33919
- Florida Cancer Specialists
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health National Cancer Institute
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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Boston, Massachusetts, United States, 02210
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02210
- Dana-Farber Cancer lnstitute
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Missouri
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Springfield, Missouri, United States, 65804
- St. John's Hospital,
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New York
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New York, New York, United States, 10022
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, United States, 11794-9446
- Stony Brook University Medical Center - Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Investigational Drug Service, Pharmacy Department, UNC Hospitals
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Chapel Hill, North Carolina, United States, 27599-7600
- UNC Hospitals, The University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, United States, 27599-2008
- Division of Hemotology/Oncology
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Durham, North Carolina, United States, 27710
- Morris Cancer Center
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Legacy Pharma Research
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Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic, P.C
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology & Hematology Associates, P.C.
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Nashville, Tennessee, United States, 37203 (Administration)
- Sarah Cannon Research Institute
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Nashville, Tennessee, United States, 37203(Pharmacy)
- Sarah Cannon Research Institute
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Virginia
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Richmond, Virginia, United States, 23230
- Virginia Cancer Institute
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Washington
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Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
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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).
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.
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Experimental: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
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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).
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) at Month 4: Cohort A
Time Frame: Baseline up to Month 4
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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.
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Baseline up to Month 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-Free Survival (PFS) at Month 4: Cohort B
Time Frame: Baseline up to Month 4
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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.
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Baseline up to Month 4
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Progression-Free Survival (PFS)
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.
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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.
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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.
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Best Overall Response (BOR)
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.
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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.
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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.
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Duration of Response (DR)
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.
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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.
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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.
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Overall Survival (OS)
Time Frame: Randomization until death or last date known to be alive.
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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).
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Randomization until death or last date known to be alive.
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Time Frame: Baseline (Cycle [C]1 Day 1), up to C75
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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.
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Baseline (Cycle [C]1 Day 1), up to C75
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
Time Frame: Baseline (C1D1) up to C75
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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.
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Baseline (C1D1) up to C75
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Trough Plasma Concentrations (Ctrough) of Dacomitinib
Time Frame: Predose on C1D14, C2D1, C3D1, C4D1
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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).
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Predose on C1D14, C2D1, C3D1, C4D1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2009
Primary Completion (Actual)
April 27, 2012
Study Completion (Actual)
April 30, 2015
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 6, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Actual)
January 8, 2019
Last Update Submitted That Met QC Criteria
December 19, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A7471017
- 2011-002794-39 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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