Safety And Efficacy Of Bosutinib

NCT02501330

Last updated date
Study Location
Shibuya-ku, , 151-8589, Japan
Contact
1-800-718-1021

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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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myelogenous Leukemia
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

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


- Patients with a history of hypersensitivity


- Women who may possibly be pregnant or become pregnant

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Advanced Information
Descriptive Information
Brief Title Safety And Efficacy Of Bosutinib
Official Title DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
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.
Detailed Description The patients should be registered by central registration system.
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 The patients who have been treated with Bosutinib
Condition Chronic Myelogenous Leukemia
Intervention 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
Study Groups/Cohorts Bosutinib
Intervention: Drug: Bosutinib
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: July 15, 2015)
659
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 7, 2023
Estimated Primary Completion Date August 7, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02501330
Other Study ID Numbers B1871036
Has Data Monitoring Committee No
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020