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Safety And Efficacy Of Bosutinib

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Shibuya-ku, , 151-8589 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myelogenous Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there
is no experience with this drug

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with a history of hypersensitivity

- Women who may possibly be pregnant or become pregnant

NCT02501330
Pfizer
Recruiting
Safety And Efficacy Of Bosutinib

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Chronic Myelogenous Leukemia
NCT02501330
All Genders
0+
Years
Shibuya-ku,
Descriptive Information
Brief TitleSafety And Efficacy Of Bosutinib
Official TitleDRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
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.
Detailed DescriptionThe patients should be registered by central registration system.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients who have been treated with Bosutinib
ConditionChronic Myelogenous Leukemia
InterventionDrug: Bosutinib
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.
Other Name: BOSULIF
Study Groups/CohortsBosutinib
Intervention: Drug: Bosutinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: November 21, 2018)
1
Original Estimated Enrollment
 (submitted: July 15, 2015)
659
Estimated Study Completion DateSeptember 4, 2023
Estimated Primary Completion DateSeptember 4, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02501330
Other Study ID NumbersB1871036
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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