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NCT02501330 Clinical Trial

Safety And Efficacy Of Bosutinib

Chronic Myelogenous Leukemia Clinical Trial

— BLF  

Official title:
DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02501330
Other study ID # B1871036
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2015
Est. completion date February 28, 2024

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

The patients should be registered by central registration system.

Recruitment information / eligibility
Status Completed
Enrollment 702
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse drug reactions 24 weeks
Primary Cytogenetic response 24 weeks
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