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Trial record 1 of 1 for:    NCT04155541
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Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155541
Recruitment Status : Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
EGFR Mutation-positive Inoperable or Reccrent NSCLC Drug: dacomitinib hydrate

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Study Type : Observational
Estimated Enrollment : 888 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation for Vizimpro Tablets
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : December 3, 2024
Estimated Study Completion Date : December 3, 2024

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




Primary Outcome Measures :
  1. The number and proportion of patients with ILD (interstitial lung disease) [ Time Frame: 52 weeks form the start date ]
    The number and proportion of patients with ILD (interstitial lung disease) will be tabulated by subgroup by risk factor


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 52 weeks from the start date ]
    Response rate will be calculated. The response rate is defined as the propotion of patients with a best ovarall response of CR ro PR in the effectiveness analysis set.

  2. The number and popuration of patients with adverse reactions [ Time Frame: 52 weeks from the start date ]
    The number and popuration of patients with adverse reactions will be tabulated.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)

Exclusion Criteria:

  • Exclusion criteria is not provided in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155541


Locations
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Japan
Pfizer
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04155541    
Other Study ID Numbers: A7471048
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Keywords provided by Pfizer:
VIZIMPRO
EGFR mutation-positive inoperable or recurrent NSCLC
non-small cell lung cancer