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BLF: Safety And Efficacy Of Bosutinib

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02501330
Collaborator
(none)
659
Enrollment
1
Location
97.2
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Detailed Description

The patients should be registered by central registration system.

Study Design

Study Type:
Observational
Anticipated 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 :
Jul 1, 2015
Anticipated Primary Completion Date :
Aug 7, 2023
Anticipated Study Completion Date :
Aug 7, 2023

Arms and Interventions

Arm 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 Names:
  • BOSULIF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of adverse drug reactions [24 weeks]

    2. Cytogenetic response [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shibuya-ku Japan 151-8589

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02501330
    Other Study ID Numbers:
    • B1871036
    First Posted:
    Jul 17, 2015
    Last Update Posted:
    Dec 31, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Drug use investigation in Japan
    Additional relevant MeSH terms:
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive

    Study Results

    No Results Posted as of Dec 31, 2020