Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

NCT ID: NCT04155541

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-24

Study Completion Date

2025-04-25

Brief Summary

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Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Detailed Description

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Conditions

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EGFR Mutation-positive Inoperable or Reccrent NSCLC

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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VIZIMPRO(dacomitinib hydrate)

Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate)

dacomitinib hydrate

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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VIZIMPRO

Eligibility Criteria

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Inclusion Criteria

* patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Japan

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A7471048

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Other Identifiers

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A7471048

Identifier Type: -

Identifier Source: org_study_id

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