AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

Phase 4

Completed

• Conditions: cancer of the blood; malignant neoplasm of blood-forming tissues; 10024324

• Registration Number: NL-OMON47755
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified