Overview

This trial is active, not recruiting.

Condition chronic myelogenous leukemia
Treatment bosutinib
Targets BCR-ABL, SRC
Sponsor Pfizer
Start date July 2015
End date September 2023
Trial size 659 participants
Trial identifier NCT02501330, B1871036

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
bosutinib BOSULIF
The usual adult dosage of once 500 mg per day postprandial oral administration as bosutinib. The dosage may be adjusted according to the patient's condition, but can be increased to once 600 mg 1 day.

Primary Outcomes

Measure
The incidence of adverse drug reactions
time frame: 24 weeks
Cytogenetic response
time frame: 24 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug Exclusion Criteria: - Patients with a history of hypersensitivity - Women who may possibly be pregnant or become pregnant

Additional Information

Official title Drug Use Investigation Of Bosutinib For Cml (Post Marketing Commitment Plan)
Description The patients should be registered by central registration system.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.