Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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
- Newly-diagnosed chronic phase Chronic myelogenous leukemia patients 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
NEED INFO?
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Safety And Efficacy Of Bosutinib | ||||
| Official Title | DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN) | ||||
| Brief Summary | The objective of this surveillance is to collect information about
| ||||
| Detailed Description | The patients should be registered by central registration system. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The patients who have been treated with Bosutinib | ||||
| Condition | Chronic Myelogenous Leukemia | ||||
| Intervention | Drug: Bosutinib
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. Other Name: BOSULIF | ||||
| Study Groups/Cohorts | Bosutinib
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 Status | Recruiting | ||||
| Estimated Enrollment | 659 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | August 7, 2023 | ||||
| Estimated Primary Completion Date | August 7, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
| ||||
| Listed Location Countries | Japan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT02501330 | ||||
| Other Study ID Numbers | B1871036 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | December 2020 | ||||