Chronic Myeloid Leukemia (CML) MedDRA version: 16.0 Level: LLT Classification code 10009012 Term: Chronic myelogenous leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bosulif 100 mg film-coated tablets
Product Name: Bosutinib
Product Code: PF-05208763
SKI-606
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bosutinib
CAS Number: 380843-75-4
Current Sponsor code: PF-05208763
SKI-606
Other descriptive name: SKI-606 monohydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 2. Previous enrollment in the bosutinib arm of one of the two Pfizer parent studies: B1871006 or B1871008. This includes: a. Subjects still receiving bosutinib in either study B1871006 or B1871008; b. Subjects who have discontinued bosutinib but are still in the long term follow up phase of the study B1871006 or B1871008; c. Subjects from study B1871006 who have discontinued bosutinib and have already completed the long term follow up period. 3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Participation in other studies involving investigational drug(s) (Phases 1 to 4) while subject in the active treatment phase of the current study. 2. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial. 3. Other severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 4. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 30 days after last dose of investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To allow long term bosutinib treatment in subjects with chronic or advanced phases Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (ie, studies B1871006 and B1871008) and who have the potential, as judged by the investigator, to derive clinical benefit from continued treatment with bosutinib; • To collect long term safety and efficacy data for bosutinib; • To assess the duration of clinical benefit for Ph+ CML subjects treated with bosutinib; • To fulfill the European Medicines Agency (EMA) post approval requirement for the collection and analysis of safety data about diarrhea incidence after switch from clinical study to commercial bosutinib formulation.;Secondary Objective: Not applicable;Primary end point(s): 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. In addition, study endpoints to be reported and data to be collected, specifically efficacy data, are planned to be different in the first line CP subjects relative to the later line and advanced subjects. For all subjects regardless of the line of treatment: • Long term safety of bosutinib, including type, incidence, severity, timing, seriousness and relatedness of AEs and laboratory abnormalities as well as reason of treatment discontinuation. A special focus will be made on diarrhea in order to satisfy the EMA post commitment request; • BCR ABL mutations present at the time subjects discontinue bosutinib; • Overall survival (OS), For 2nd or later line subjects coming from study B1871006: as long as subjects are on treatment with bosutinib, the following efficacy endpoints will be assessed: • Duration of hematologic and cytogenetic responses; • Progression free survival; • Time to transformation to accelerated or blast phase.;Timepoint(s) of evaluation of this end point | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed