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The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.
The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dacomitinib | Experimental | 3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dacomitinib | Drug | Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study | To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. |
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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 |
|---|---|---|---|---|---|---|
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 9208641 | Japan | ||
| Kurashiki Central Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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It is a multi-center,treatment extension study open in Japan only.Eligible participants were those with advanced non-small cell lung cancer who received and tolerated dacomitinib in studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]) in Japan and had the potential to derive continued clinical benefit based on investigator judgment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dacomitinib | Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population included all participants who received any study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dacomitinib | Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study | To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment. | All participants who received any study medication. | Posted | Count of Participants | Participants | 4 years |
|
Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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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 | Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]). Dacomitinib was provided as tablets for oral administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2015 | May 26, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2019 | May 26, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C525726 | dacomitinib |
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|
| Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks |
| Kurashiki |
| Okayama-ken |
| 710-8602 |
| Japan |
| Osaka City General Hospital Department of Clinical Oncology | Osaka | Osaka | 534-0021 | Japan |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Shizuoka Cancer Center | Suntougun | Shizuoka | 411-8777 | Japan |
| Cancer Institute Hospital,Japanese Foundation for Cancer Research | Koto-Ku | Tokyo | 135-8550 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. | All participants who received any study medication. | Posted | Count of Participants | Participants | Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks |
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| 7 |
| 7 |
| Lung infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Corneal erosion | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Swelling of eyelid | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Pleural infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
|
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.