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CompletedNCT02501330BLFUpdated Jul 10, 2026

Safety And Efficacy Of Bosutinib

An observational study in Chronic Myelogenous Leukemia, sponsored by Pfizer. Completed. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
702
Ages
0 Years and older
Sex
All
01

Study 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.
Read the detailed description

The patients should be registered by central registration system.

02

Conditions studied

  • Chronic Myelogenous Leukemia

Keywords

  • Drug use investigation in Japan
03

In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's enrollment of 702 is above the median of 141 across 149 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients who have been treated with Bosutinib

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

Exclusion Criteria:

  • Patients with a history of hypersensitivity
  • Women who may possibly be pregnant or become pregnant
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
702 participants (actual)
Patient registry
No

Groups and cohorts

  • Bosutinib

    Drug: Bosutinib

Interventions

  • DrugBosutinib

    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.

    Also known as: BOSULIF

06

What researchers measure

Primary outcomes

  1. The incidence of adverse drug reactions

    Time frame: 24 weeks

  2. Cytogenetic response

    Time frame: 24 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02501330
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jul 17, 2015
Start date
Jul 1, 2015
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024
Last update
Jul 10, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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