Safety And Efficacy Of Bosutinib
BLF
DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
1 other identifier
observational
702
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedApril 30, 2024
April 1, 2024
8.7 years
July 15, 2015
April 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The incidence of adverse drug reactions
24 weeks
Cytogenetic response
24 weeks
Study Arms (1)
Bosutinib
Interventions
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.
Eligibility Criteria
The patients who have been treated with Bosutinib
You may qualify if:
- 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
You may not qualify if:
- Patients with a history of hypersensitivity
- Women who may possibly be pregnant or become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Unknown Facility
Shibuya-ku, 151-8589, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 17, 2015
Study Start
July 1, 2015
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
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.