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Bosulif (Bosutinib Monohydrate) - Summary

 
 



BOSULIF SUMMARY

Bosutinib is a kinase inhibitor.

BOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.


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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.

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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.

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Page last updated: 2014-11-30

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