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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155541
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 5, 2019
First Posted Date November 7, 2019
Last Update Posted Date November 7, 2019
Estimated Study Start Date November 29, 2019
Estimated Primary Completion Date December 11, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 5, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not yet recruiting
Estimated Enrollment
 (submitted: November 5, 2019)
888
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 11, 2023
Estimated Primary Completion Date December 11, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Not Provided
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
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2019