cancer of the blood malignant neoplasm of blood-forming tissues
Conditions
Interventions
This is an open-label bosutinib treatment extension protocol. This protocol
will be offered to those bosutinib patients who were previously enrolled in one
of the two parent CML bosutinib studies (B
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients 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 patient (or a legal representative) has been informed of all pertinent aspects of the study. 1. Previous enrollment in the bosutinib arm of one of the two Pfizer parent Studies : B1871006 or B1871008. This includes: a. Patients still receiving bosutinib in either Study B1871006 or Study B1871008; b. Patients who have discontinued bosutinib but are still in the long term follow-up phase of the Study B1871006 or B1871008; c. Patients from study B1871006 who have discontinued bosutinib and have already completed the long term follow-up period. 3. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4. Male and female patients 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 patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. In order to be considered a female of non-childbearing potential the patient must meet at least 1 of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause or a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed and documented ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the study: 1. Participation in other studies involving investigational drug(s) (Phases 1-4) while patient in the active treatment phase of the current study. 2. Patients 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 patients 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 patients inappropriate for entry into this study. 4. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, data to be collected are planned to be different in the first line CP patients relative to the later line and advanced subjects. For all patients regardless of the line of treatment: - Long term safety of bosutinib, including type, incidence, severity, timing, seriousness and relatedness of adverse events (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 patients discontinue Bosutinib. (For all patients except those enrolled at sites in China) - Overall survival (OS). - Fulfill the EMA post-approval requirement to compare the pharmacokinetic analysis of Ctrough of bosutinib in this study to Ctrough of previous studies. For 2nd or later line patients coming from study B1871006 who are still 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. | — |
Countries
Netherlands
Outcome results
None listed