Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
NCT04155541
Last updated date
ABOUT THIS STUDY
Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical
practice
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
EGFR Mutation-positive Inoperable or Reccrent NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Exclusion criteria is not provided in this study
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EGFR Mutation-positive Inoperable or Reccrent NSCLCSpecial Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
NCT04155541
- Tokyo,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice) | ||||
| Official Title | Special Investigation for Vizimpro Tablets | ||||
| Brief Summary | Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The patient who meet the inclusion criteria and who were registered to this study within 28 days including the start date of treatment with this product will be subjects for this study. | ||||
| Condition | EGFR Mutation-positive Inoperable or Reccrent NSCLC | ||||
| Intervention | Drug: dacomitinib hydrate
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. Other Name: VIZIMPRO | ||||
| Study Groups/Cohorts | VIZIMPRO(dacomitinib hydrate)
Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate) Intervention: Drug: dacomitinib hydrate | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment | 888 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 3, 2026 | ||||
| Estimated Primary Completion Date | May 2026 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04155541 | ||||
| Other Study ID Numbers | A7471048 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | March 2021 | ||||