At a glance
ClinicalIndex Comparison RecordN/ACompleted· 281 enrolled
Drug / intervention
bosutinibdrug
Likely dose
bosutinib 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008
In Brief
A clinical study evaluating bosutinib for Chronic Myeloid Leukemia. Completed, enrolled 281 participants across 91 sites in 29 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia
CountriesArgentina, 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, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartAug 2013
Primary CompletionJun 2020
TodayJul 2026
First PostedJul 19, 2013
Enrollment StartAug 28, 2013
Primary CompletionJun 5, 2020
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 13.0 years ago
Interventions
bosutinibdrug
The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.