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Safety and Efficacy of Lorbrena

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: NCT03844464
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 15, 2019
First Posted Date February 18, 2019
Last Update Posted Date June 22, 2020
Actual Study Start Date January 21, 2019
Estimated Primary Completion Date August 11, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2019)
Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction [ Time Frame: 52 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 August 11, 2023
Estimated Primary Completion Date August 11, 2023   (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_Inquiries@pfizer.com
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/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 June 2020