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.
- Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there
is no experience with this drug
- Patients with a history of hypersensitivity
- Women who may possibly be pregnant or become pregnant
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 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/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 | 1 | ||||
| Original Estimated Enrollment | 659 | ||||
| Estimated Study Completion Date | September 4, 2023 | ||||
| Estimated Primary Completion Date | September 4, 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 | June 2019 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
