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

Last updated on November 18, 2019

FOR MORE INFORMATION
Study Location
Contact
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
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

NCT04155541
Pfizer
Not yet recruiting
Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

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Descriptive Information
Brief TitleSpecial Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
Official TitleSpecial Investigation for Vizimpro Tablets
Brief SummarySecondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe 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.
ConditionEGFR Mutation-positive Inoperable or Reccrent NSCLC
InterventionDrug: 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/CohortsVIZIMPRO(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 StatusNot yet recruiting
Estimated Enrollment
 (submitted: November 5, 2019)
888
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 11, 2023
Estimated Primary Completion DateDecember 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT04155541
Other Study ID NumbersA7471048
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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