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Safety and Efficacy of Lorbrena

Last updated on January 24, 2020

FOR MORE INFORMATION
Study Location
3-22-7, Yoyogi, Shibuya-ku
Tokyo, , 151-8589 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer
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

- All administered patients

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Nothing

NCT03844464
Pfizer
Recruiting
Safety and Efficacy of Lorbrena

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title Safety and Efficacy of Lorbrena
Official Title Special Investigation for LORBRENA Tablets
Brief Summary

To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug

  1. Factors affecting the onset of central nervous system disorder
  2. Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction
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 651 patients
Condition Non-small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: February 15, 2019)
651
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 20, 2021
Estimated Primary Completion Date September 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All administered patients

Exclusion Criteria:

  • Nothing
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[email protected]
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03844464
Other Study ID Numbers B7461018
Has Data Monitoring Committee Not Provided
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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

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

BY EMAIL

Contact

[email protected]

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