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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 : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease
Non-small Cell Lung Cancer

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Study Type : Observational
Estimated Enrollment : 651 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation for LORBRENA Tablets
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction [ Time Frame: 52 weeks ]


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
651 patients
Criteria

Inclusion Criteria:

  • All administered patients

Exclusion Criteria:

  • Nothing

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): NCT03844464


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
3-22-7, Yoyogi, Shibuya-ku Recruiting
Tokyo, Japan, 151-8589
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: NCT03844464     History of Changes
Other Study ID Numbers: B7461018
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
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.
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases