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Safety And Efficacy Of Bosutinib (BLF)

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: NCT02501330
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

The objective of this surveillance is to collect information about

  1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
  2. the incidence of adverse drug reactions in this surveillance
  3. factors considered to affect the safety and/or efficacy of this drug.

Condition or disease Intervention/treatment
Chronic Myelogenous Leukemia Drug: Bosutinib

Detailed Description:
The patients should be registered by central registration system.
Study Design
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Study Type : Observational
Estimated Enrollment : 659 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : March 7, 2024
Estimated Study Completion Date : March 7, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib

Groups and Cohorts
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Group/Cohort Intervention/treatment
Bosutinib Drug: Bosutinib
The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily.
Other Name: BOSULIF


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of adverse drug reactions [ Time Frame: 24 weeks ]
  2. Cytogenetic response [ Time Frame: 24 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients who have been treated with Bosutinib
Criteria

Inclusion Criteria:

  • Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
  • Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug

Exclusion Criteria:

  • Patients with a history of hypersensitivity
  • Women who may possibly be pregnant or become pregnant
Contacts and Locations
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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): NCT02501330


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
Recruiting
Shibuya-ku, Japan, 151-8589
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02501330    
Other Study ID Numbers: B1871036
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
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.
Keywords provided by Pfizer:
Drug use investigation in Japan
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Chronic Disease
Disease Attributes
Pathologic Processes