A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
NCT02546375
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Adult Trials: 18+ Years
- Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
- Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 OR via the compassionate use programme prior to marketing authorization.
- Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Prescribed bosutinib as part of an interventional clinical trial programme.
- Initiated on bosutinib less than 3 months prior to data collection taking place.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands | ||||
| Official Title | A RETROSPECTIVE OBSERVATIONAL RESEARCH STUDY TO DESCRIBE THE REAL WORLD USE OF BOSUTINIB IN THE UK AND NETHERLANDS | ||||
| Brief Summary | The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | CML out-patient clinics | ||||
| Condition | Chronic Myeloid Leukaemia | ||||
| Intervention | Drug: Bosutinib
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study) Other Name: Bosulif | ||||
| Study Groups/Cohorts | Chronic Myeloid Leukaemia
Patients diagnosed with chronic myeloid leukaemia treated with 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 | Completed | ||||
| Actual Enrollment | 87 | ||||
| Original Estimated Enrollment | 100 | ||||
| Actual Study Completion Date | January 16, 2017 | ||||
| Actual Primary Completion Date | January 16, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender | Not Provided | ||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT02546375 | ||||
| Other Study ID Numbers | B1871052 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | pH Associates | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | May 2019 | ||||