NEWS HIGHLIGHTS
Published Studies Related to Bosulif (Bosutinib)
Pharmacokinetic-pharmacodynamic relationship of bosutinib in patients with
chronic phase chronic myeloid leukemia. [2013] potential bosutinib pharmacokinetic-pharmacodynamic relationships... CONCLUSIONS: The absence of exposure-response relationships for some safety and
Effect of ketoconazole on the pharmacokinetics of oral bosutinib in healthy
subjects. [2011] Bosutinib (SKI-606), a dual inhibitor of Src and Abl tyrosine kinases, is being
developed for the treatment of chronic myelogenous leukemia. The effect of
coadministration of ketoconazole on the pharmacokinetic (PK) profile of bosutinib
was evaluated in an open-label, randomized, 2-period, crossover study.
Clinical Trials Related to Bosulif (Bosutinib)
Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive Philadelphia-Chromosome (PC) Positive Acute Lymphoblastic Leukemia (ALL) and Chronic Myeloid Leukemia (CML) [Recruiting]
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of
the combination of bosutinib and inotuzumab ozogamicin that can be given to patients with
Ph+ ALL and CML in the lymphoid blast phase that also expresses CD22.
The goal of Part 2 is to learn if the dose found in Part 1 can help to control the disease.
The safety of this drug combination will also be studied.
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects [Completed]
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors [Recruiting]
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to
the European Medicines Agency in providing additional safety and efficacy data in
approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with
high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase
patients in the fourth or later line treatment setting (i. e., after treatment with at least
3 other Tyrosine Kinase Inhibitors).
Safety And Efficacy Of Bosutinib [Active, not recruiting]
The objective of this surveillance is to collect information about
1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
2. the incidence of adverse drug reactions in this surveillance
3. factors considered to affect the safety and/or efficacy of this drug.
Bosutinib For Autosomal Dominant Polycystic Kidney Disease [Completed]
This purpose of this study is to determine if bosutinib reduces the rate of kidney
enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering
the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than
or equal to 60 mL/min/1. 73m2.
|