A Phase 1 interventional study of Bosutinib in Breast Cancer and Leukemia, Myeloid, Chronic, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-16.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1 and Interventional
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
2,443 studies on the registry are indexed under Leukemia, Myeloid; 210 are open to participants now.
This study's enrollment of 27 is below the median of 40 across 1,977 interventional studies indexed under Leukemia, Myeloid.
Browse Leukemia, Myeloid studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.
WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone [FSH] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration.
Exclusion criteria (for both study populations):
Other inclusion and exclusion criteria apply.
Drug: Bosutinib
Blood samples
Time frame: 5 weeks
Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
Time frame: 5 weeks
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Wyeth is now a wholly owned subsidiary of Pfizer