Safety And Efficacy Of Bosutinib

NCT ID: NCT02501330

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

702 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2024-02-28

Brief Summary

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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

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The patients should be registered by central registration system.

Conditions

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Chronic Myelogenous Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bosutinib

Bosutinib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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BOSULIF

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Shibuya-ku, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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B1871036

Identifier Type: -

Identifier Source: org_study_id

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