The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.
- Only subjects previously participating in two specific studies are eligible to enroll
into this study. Enrollment is not open to subjects if not previously enrolled in
studies B1871006 or B1871008.
- All subjects are excluded unless previously participating in studies B1871006 or
B1871008.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008 | ||||
| Official Title ICMJE | AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008 | ||||
| Brief Summary | The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Masking: None (Open Label) | ||||
| Condition ICMJE | Chronic Myeloid Leukemia | ||||
| Intervention ICMJE | Drug: bosutinib The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg. | ||||
| Study Arms ICMJE | Not Provided | ||||
| 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 ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE | 282 | ||||
| Original Enrollment ICMJE | Not Provided | ||||
| Estimated Study Completion Date ICMJE | May 15, 2020 | ||||
| Estimated Primary Completion Date | May 15, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Finland, France, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Netherlands, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States | ||||
| Removed Location Countries | Lithuania | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01903733 | ||||
| Other Study ID Numbers ICMJE | B1871040 2013-000691-15 ( EudraCT Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | April 2019 | ||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||
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
