Trials / Completed
CompletedNCT01903733
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 281 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bosutinib | The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg. |
Timeline
- Start date
- 2013-08-28
- Primary completion
- 2020-06-05
- Completion
- 2020-06-05
- First posted
- 2013-07-19
- Last updated
- 2022-07-19
- Results posted
- 2021-08-17
Locations
91 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Finland, France, Hong Kong, Hungary, India, Italy, Japan, Latvia, Netherlands, Peru, Poland, Russia, Singapore, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01903733. Inclusion in this directory is not an endorsement.