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

Pfizer Inc, 235 East 42nd Street, New York, NY 100170 个研究点目标入组 820 人开始时间: 2013年6月10日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•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

•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.

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