A clinical trial to to collect long term safety and efficacy data for bosutinib in patients with Chronic Myelogenous Leukemia (CML).
- Conditions
- Health Condition 1: null- Chronic Myelogenous Leukemia (CML)
- Registration Number
- CTRI/2015/01/005461
- Lead Sponsor
- Wyeth Pharmaceuticals India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 stude 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.
Subjects presenting with any of the following will not be included in the study:
1. Participation in other studies involving investigational drug(s) (Phases 1-4) 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.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 <br/ ><br>2.BCR -ABL mutations present at the time subjects discontinue bosutinib <br/ ><br>3.Overall survival (OS)Timepoint: Disease status for pts is assessed according to local SOC.1st-line chronic phase pts will be followed for safety,survival&BCR-ABL mutation status,study visits-12months&phone visit-3months. 2nd&later line pts have visits-6months&phone visit-3months, At all visits emphasis will be on dosing compliance&patient safety.Efficacy assessed includes duration of hematologic&cytogenetic response,progression-free survival&time to transformation from accelerated to blast phase disease.
- Secondary Outcome Measures
Name Time Method Duration of hematologic and cytogenetic responses.Timepoint: NA;Progression free survival.Timepoint: NA;Time to transformation to accelerated or blast phase.Timepoint: NA