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This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor. |
|
| Cohort B | Experimental | Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dacomitinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) in Participants With T790M Mutation | BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective. | From baseline until disease progression, up to 61 weeks. |
| Objective Response Rate (ORR) in Participants With T790M Mutation | ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective. | From baseline to disease progression, up to 61 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) for Participants With T790M Mutation | DCR was calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST, v1.1, relative to the total number of participants enrolled in the cohort. If baseline tumor assessment was inadequate for a participant, and the participant could not be assessed for RECIST responses and had no objective status of stable disease documented at least 6 weeks after the start date and before the progression, the participant was only counted in the denominator. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. DCR was analyzed only for participants with T790M mutation according to the study objective. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower Hematology Oncology Medical Group | Beverly Hills | California | 90211 | United States | ||
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31858327 | Derived | 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. | |
| 29191595 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Of 41 participants enrolled in the study, 38 (16 with T790M mutation and 22 without T790M mutation) received study drug. Three of the enrolled participants without known T790M mutation did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dacomitinib, 45/60 mg, With T790M Mutation | Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dacomitinib | Drug | 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. |
|
| From baseline to baseline to disease progression, up to 61 weeks. |
| Duration of Response in Participants With T790M Mutation | Duration of response was defined as the time from first documentation of response (CR or PR, whichever occurred first) to the date of disease progression or to death due to any cause, whichever occurred first. CR and PR were defined using RECIST, v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. DR was only calculated and summarized for the subgroup of participants with an objective tumor response in the cohort of participants with T790M mutation. | From baseline to date of disease progression or death, up to 61 weeks. |
| Progression-free Survival | Progression-free survival was defined as the time from the date of first dosing of dacomitinib to the date of disease progression by RECIST v1.1, per the investigators' assessment, or death due to any cause, whichever occurred first. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. | From baseline to disease progression or death, up to 61 weeks. |
| Progression-free Survival at 4 Months | Progression-free survival at 4 months was defined as the percentage of participants who were alive without disease progression at 4 months relative to all participants enrolled. Disease progression was defined by RECIST v1.1. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. | Month 4 |
| Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265 | Cmax was observed directly from data. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate. | Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. |
| Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265 | Tmax was observed directly from data as time of first occurrence. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate. | Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. |
| Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG) | ECGs recorded on Day 1 of Cycle 0 were used as baseline. For the ECGs assessments, the following directions were followed by the ECG central laboratory: Blinding of ECG readers to treatment, time, and day identifiers. Review of ECGs from a particular participant was performed by a single reader. Prespecification of the lead for internal measurements. Baseline and on-treatment ECG assessments were based on the same lead. | From Baseline to Cycle 0, Day 4 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Georgetown University Hospital-Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Georgetown University Medical Center Department of Pharmacy, Research | Washington D.C. | District of Columbia | 20007 | United States |
| Memorial Sloan-Kettering Cancer Center-Rockefeller Outpatient Pavilion | New York | New York | 10022 | United States |
| Investigational Drug Service, Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UT Southwestern Medical Center-Simmons Cancer Center Pharmacy | Dallas | Texas | 75390-9015 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - William P. Clements, Jr. | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - Zale Lipshy | Dallas | Texas | 75390 | United States |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| 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. |
| FG001 | Dacomitinib, 45/60 mg, Without T790M Mutation | Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dacomitinib, 45/60 mg, With T790M Mutation | Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor. |
| BG001 | Dacomitinib, 45/60 mg, Without T790M Mutation | Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Overall Response (BOR) in Participants With T790M Mutation | BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective. | All enrolled participants with T790M mutation | Posted | Number | Participants | From baseline until disease progression, up to 61 weeks. |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) for Participants With T790M Mutation | DCR was calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST, v1.1, relative to the total number of participants enrolled in the cohort. If baseline tumor assessment was inadequate for a participant, and the participant could not be assessed for RECIST responses and had no objective status of stable disease documented at least 6 weeks after the start date and before the progression, the participant was only counted in the denominator. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. DCR was analyzed only for participants with T790M mutation according to the study objective. | All enrolled participants with T790M mutation | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline to baseline to disease progression, up to 61 weeks. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response in Participants With T790M Mutation | Duration of response was defined as the time from first documentation of response (CR or PR, whichever occurred first) to the date of disease progression or to death due to any cause, whichever occurred first. CR and PR were defined using RECIST, v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. DR was only calculated and summarized for the subgroup of participants with an objective tumor response in the cohort of participants with T790M mutation. | All enrolled participants with T790M mutation status who had an objective tumor response (complete or partial response) | Posted | Number | Months | From baseline to date of disease progression or death, up to 61 weeks. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival was defined as the time from the date of first dosing of dacomitinib to the date of disease progression by RECIST v1.1, per the investigators' assessment, or death due to any cause, whichever occurred first. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. | All enrolled participants | Posted | Median | 95% Confidence Interval | Months | From baseline to disease progression or death, up to 61 weeks. |
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| Secondary | Progression-free Survival at 4 Months | Progression-free survival at 4 months was defined as the percentage of participants who were alive without disease progression at 4 months relative to all participants enrolled. Disease progression was defined by RECIST v1.1. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. | All enrolled participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 4 |
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| Primary | Objective Response Rate (ORR) in Participants With T790M Mutation | ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective. | All enrolled participants with T90M mutation | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline to disease progression, up to 61 weeks. |
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| Secondary | Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265 | Cmax was observed directly from data. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate. | All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265 | Tmax was observed directly from data as time of first occurrence. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate. | All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265. | Posted | Median | Full Range | Hours | Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. |
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| Secondary | Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG) | ECGs recorded on Day 1 of Cycle 0 were used as baseline. For the ECGs assessments, the following directions were followed by the ECG central laboratory: Blinding of ECG readers to treatment, time, and day identifiers. Review of ECGs from a particular participant was performed by a single reader. Prespecification of the lead for internal measurements. Baseline and on-treatment ECG assessments were based on the same lead. | All participants who received all scheduled doses of dacomitinib and had all ECGs performed on Days 1-4 of Cycle 0 (n=number evaluable) | Posted | Mean | 90% Confidence Interval | msecs | From Baseline to Cycle 0, Day 4 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dacomitinib, 45/60 mg, With T790M Mutation | Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor. | 7 | 16 | 16 | 16 | ||
| EG001 | Dacomitinib, 45/60 mg, Without T790M Mutation | Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. | 8 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Chest pain | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Hyperbilirubinaemia | Hepatobiliary disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Hip fracture | Injury, poisoning and procedural complications |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Failure to thrive | Metabolism and nutrition disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Muscular weakness | Musculoskeletal and connective tissue disorders |
| |||
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Mental status changes | Psychiatric disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| |||
| Leukocytosis | Blood and lymphatic system disorders |
| |||
| Lymphadenopathy | Blood and lymphatic system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Tachycardia | Cardiac disorders |
| |||
| Tinnitus | Ear and labyrinth disorders |
| |||
| Conjunctivitis allergic | Eye disorders |
| |||
| Dry eye | Eye disorders |
| |||
| Eye irritation | Eye disorders |
| |||
| Lacrimation increased | Eye disorders |
| |||
| Vision blurred | Eye disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Aphthous ulcer | Gastrointestinal disorders |
| |||
| Cheilitis | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Haematochezia | Gastrointestinal disorders |
| |||
| Lip disorder | Gastrointestinal disorders |
| |||
| Lip pain | Gastrointestinal disorders |
| |||
| Mouth ulceration | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Oesophagitis | Gastrointestinal disorders |
| |||
| Oral dysaesthesia | Gastrointestinal disorders |
| |||
| Oral mucosal erythema | Gastrointestinal disorders |
| |||
| Oral pain | Gastrointestinal disorders |
| |||
| Proctalgia | Gastrointestinal disorders |
| |||
| Retching | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Chest pain | General disorders |
| |||
| Face oedema | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Gait disturbance | General disorders |
| |||
| Influenza like illness | General disorders |
| |||
| Local swelling | General disorders |
| |||
| Mass | General disorders |
| |||
| Mucosal inflammation | General disorders |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Oedema | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Ulcer haemorrhage | General disorders |
| |||
| Xerosis | General disorders |
| |||
| Seasonal allergy | Immune system disorders |
| |||
| Carbuncle | Infections and infestations |
| |||
| Conjunctivitis | Infections and infestations |
| |||
| Diverticulitis | Infections and infestations |
| |||
| Ear infection fungal | Infections and infestations |
| |||
| Infection | Infections and infestations |
| |||
| Paronychia | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Arthropod bite | Injury, poisoning and procedural complications |
| |||
| Contusion | Injury, poisoning and procedural complications |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Ligament sprain | Injury, poisoning and procedural complications |
| |||
| Alanine aminotransferase decreased | Investigations |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Blood alkaline phosphatase increased | Investigations |
| |||
| Blood bicarbonate decreased | Investigations |
| |||
| Human chorionic gonadotropin increased | Investigations |
| |||
| Lymphocyte count decreased | Investigations |
| |||
| Neutrophil count decreased | Investigations |
| |||
| Weight decreased | Investigations |
| |||
| White blood cell count decreased | Investigations |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Hypercalcaemia | Metabolism and nutrition disorders |
| |||
| Hyperglycaemia | Metabolism and nutrition disorders |
| |||
| Hypoalbuminaemia | Metabolism and nutrition disorders |
| |||
| Hypocalcaemia | Metabolism and nutrition disorders |
| |||
| Hypokalaemia | Metabolism and nutrition disorders |
| |||
| Hyponatraemia | Metabolism and nutrition disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Flank pain | Musculoskeletal and connective tissue disorders |
| |||
| Groin pain | Musculoskeletal and connective tissue disorders |
| |||
| Muscle spasms | Musculoskeletal and connective tissue disorders |
| |||
| Muscular weakness | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Neck pain | Musculoskeletal and connective tissue disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dysgeusia | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hypoaesthesia | Nervous system disorders |
| |||
| Neuropathy peripheral | Nervous system disorders |
| |||
| Parkinson's disease | Nervous system disorders |
| |||
| Seizure | Nervous system disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Confusional state | Psychiatric disorders |
| |||
| Delirium | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Chronic kidney disease | Renal and urinary disorders |
| |||
| Dysuria | Renal and urinary disorders |
| |||
| Hydronephrosis | Renal and urinary disorders |
| |||
| Micturition urgency | Renal and urinary disorders |
| |||
| Urethral pain | Renal and urinary disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dysphonia | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal disorder | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders |
| |||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Productive cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Alopecia | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders |
| |||
| Dry skin | Skin and subcutaneous tissue disorders |
| |||
| Eczema | Skin and subcutaneous tissue disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Hair texture abnormal | Skin and subcutaneous tissue disorders |
| |||
| Nail discolouration | Skin and subcutaneous tissue disorders |
| |||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Rash maculo-papular | Skin and subcutaneous tissue disorders |
| |||
| Skin fissures | Skin and subcutaneous tissue disorders |
| |||
| Skin irritation | Skin and subcutaneous tissue disorders |
| |||
| Skin ulcer | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Lymphoedema | Vascular disorders |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C525726 | dacomitinib |
Not provided
Not provided
Not provided
|
| Between 45 and 64 years |
|
| 65 years and older |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Objective progression |
|
| Indeterminate |
|
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| Units | Counts |
|---|
| Participants |
|
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