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Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIZIMPRO(dacomitinib hydrate) | Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dacomitinib hydrate | Drug | The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Participants With Interstitial Lung Disease (ILD) | An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis. | 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation). |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1" | The response rate was calculated based on the best overall response as evaluated by the physician in accordance with the RECIST - Revised Version 1.1. The response rate was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR). In addition, the response rate and its two-sided 95% confidence interval (using exact method) were calculated. The participants not reported response were considered to have achieved a best overall response other than CR or PR. |
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Inclusion Criteria:
Exclusion Criteria:
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The patient who meet the inclusion criteria and who were registered to this study within 84 days including the start date of treatment with this product will be subjects for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Japan | Tokyo | Japan |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | VIZIMPRO Tablets 15mg and/or 45mg (Dacomitinib) Single Arm | Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 40 participants were enrolled in this study. Of the 40 enrolled participants from whom case report forms were collected, 2 participants were excluded due to no informed consent for publication of study results. The remaining 38 participants were included in the safety analysis set (SAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | VIZIMPRO Tablets 15mg and 45mg (Dacomitinib) | Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | The Number and Percentage of Participants With Interstitial Lung Disease (ILD) | An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis. | The SAS (38 participants) comprised of participants who satisfied the inclusion criteria and had received VIZIMPRO Tablets 15mg and/or 45mg. Participants who did not provide informed consent were excluded. | Posted | Count of Participants | Participants | 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation). |
|
52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
The frequency of AEs. The same event may appear as both an AE and a serious AE. 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 serious and non-serious events during the study. This study focused on ILD, but AEs other than ILD were also included in the analysis.
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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 | VIZIMPRO Tablets 15mg and 45mg (Dacomitinib) | Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
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The implementation plan stipulated that only ILD among the observed AEs was to be collected. Although events other than ILD were also collected and included in the analysis, such collection was not originally intended under the plan. Consequently, the occurrence status of non-ILD events is not considered to accurately reflect the actual situation.
| 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 | Jul 18, 2024 | Apr 1, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2025 | Apr 1, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C525726 | dacomitinib |
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|
| 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation. |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | VIZIMPRO Tablets 15mg and 45mg (Dacomitinib) | Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion. |
|
|
| Secondary | Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1" | The response rate was calculated based on the best overall response as evaluated by the physician in accordance with the RECIST - Revised Version 1.1. The response rate was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR). In addition, the response rate and its two-sided 95% confidence interval (using exact method) were calculated. The participants not reported response were considered to have achieved a best overall response other than CR or PR. | The efficacy analysis set was defined as the population of participants in the SAS, excluding those who met any one of the following conditions: disease not under investigation or no efficacy information. Seven participants were excluded due to no efficacy information. | Posted | Number | 95% Confidence Interval | Percentage of participants | 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation. |
|
|
|
| 2 |
| 38 |
| 3 |
| 38 |
| 0 |
| 38 |
| Cardiac arrest | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
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| ILD | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
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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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |