Safety And Efficacy Of Bosutinib | NCT02501330

Studies
Safety And Efficacy Of Bosutinib

NCT02501330

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jul 10, 2026Actual

Enrollment

702Actual

Phase

Not provided

Conditions

Chronic Myelogenous Leukemia

Interventions

Bosutinib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCT02501330	Registry Identifier	ClinicalTrials.gov

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Jul 15, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this surveillance is to collect information about

adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
the incidence of adverse drug reactions in this surveillance
factors considered to affect the safety and/or efficacy of this drug.

Detailed Description

The patients should be registered by central registration system.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

702Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bosutinib			Drug: Bosutinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bosutinib	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of adverse drug reactions		24 weeks
Cytogenetic response		24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who have been treated with Bosutinib

Sampling Method

Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

See Also Links

Label	URL
To obtain contact information for a study center near you, click here.	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C471992	bosutinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided