| Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008 |
| An Open-label Bosutinib Treatment Extension Study For Subjects With Chronic Myeloid Leukemia (Cml) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008 |
| 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. |
| Not Provided |
| Interventional |
| Not Provided |
| Masking: None (Open Label) |
| Chronic Myeloid Leukemia |
| Drug: bosutinib
The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.
|
| Not Provided |
| Not Provided |
| |
| Recruiting |
| 300 |
| April 3, 2020 |
| April 3, 2020 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- 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.
Exclusion Criteria:
- All subjects are excluded unless previously participating in studies B1871006 or B1871008.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
|
| 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 |
| Lithuania |
| |
| NCT01903733 |
B1871040
2013-000691-15 ( EudraCT Number ) |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| December 2017 |
