Bosutinib

Generic Name: Bosutinib

Brand Names: Bosulif

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₉Cl_₂N_₅O_₃

CAS Number: 380843-75-4

Unique Ingredient Identifier: 5018V4AEZ0

Background: Bosutinib is a 7-alkoxy-3-quinolinecarbonitrile that functions as a potent, dual SRC and ABL tyrosine kinase inhibitor indicated for chronic myelogenous leukemia (CML), specifically Philadelphia chromosome-positive (Ph+) CML. Philadelphia chromosome is a hallmark of CML due to the reciprocal translocation t(9;22)(q34;q11), resulting in a BCR-ABL fusion prote...

Indication: 用于治疗对既往治疗无效的慢性、加速期或急变期Ph+的慢性粒细胞白血病（CML）患者。

Associated Conditions: Accelerated Phase Chronic Myelogenous Leukemia (CML), Chronic Phase Chronic Myeloid Leukemia, Blast phase Chronic myeloid leukemia

Associated Therapies: -

Clinical Trials

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

Not Applicable

Completed

Conditions: Chronic Myeloid Leukemia

First Posted Date: 2013-07-19

Last Posted Date: 2022-07-19

Lead Sponsor: Pfizer

Target Recruit Count: 281

Registration Number: NCT01903733

Locations: 🇦🇷
Hospital Italiano de la Plata, La Plata, Buenos Aires, Argentina
🇫🇷
CHU de CAEN, Caen Cedex 9, France
🇮🇹
ASST Monza - Ospedale san Gerardo, Monza, Monza AND Brianza, Italy

and more 87 locations

Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Phase 1

Completed

Conditions: Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Interventions: Drug: Bosutinib

First Posted Date: 2011-06-15

Last Posted Date: 2011-11-30

Lead Sponsor: Pfizer

Target Recruit Count: 88

Registration Number: NCT01374139

Locations: 🇸🇬
Pfizer Investigational Site, Singapore, Singapore

Bosutinib in Adult Patients With Recurrent Glioblastoma

Phase 2

Completed

Conditions: Glioblastoma

Interventions: Drug: bosutinib

First Posted Date: 2011-04-08

Last Posted Date: 2016-07-25

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 36

Registration Number: NCT01331291

Locations: 🇺🇸
Dana=Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Bosutinib In Subjects With Renal Impairment

Phase 1

Completed

Conditions: Renal Disease, End-Stage
Renal Insufficiency, Chronic
Renal Insufficiency, Acute

Interventions: Drug: Bosutinib

First Posted Date: 2010-11-03

Last Posted Date: 2012-07-03

Lead Sponsor: Pfizer

Target Recruit Count: 34

Registration Number: NCT01233882

Locations: 🇺🇸
Pfizer Investigational Site, Saint Paul, Minnesota, United States

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Phase 2

Completed

Conditions: Polycystic Kidney, Autosomal Dominant

Interventions: Drug: Placebo
Drug: Bosutinib

First Posted Date: 2010-11-03

Last Posted Date: 2016-03-11

Lead Sponsor: Pfizer

Target Recruit Count: 172

Registration Number: NCT01233869

Locations: 🇨🇦
Toronto General Hospital, Toronto, Ontario, Canada
🇺🇸
Southwest Kidney Institute, PLC, Tempe, Arizona, United States
🇺🇸
Capital Nephrology Clinical Research, Sacramento, California, United States

and more 61 locations

Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

Phase 1

Terminated

Conditions: Advanced Breast Cancer (Parts 1 and 2)
Advanced Pancreatic Cancer (Part 1)
Advanced Colorectal Cancer (Part 1)
Advanced Cholangiocarcinoma (Part 1)
Advanced Glioblastoma Multiforme (Part 1)

Interventions: Drug: Bosutinib
Drug: Capecitabine

First Posted Date: 2009-08-17

Last Posted Date: 2013-02-22

Lead Sponsor: Pfizer

Target Recruit Count: 32

Registration Number: NCT00959946

Locations: 🇪🇸
Pfizer Investigational Site, Madrid, Spain

Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Bosutinib
Drug: Lansoprazole

First Posted Date: 2009-08-06

Last Posted Date: 2011-04-19

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Target Recruit Count: 24

Registration Number: NCT00952913

Locations: 🇺🇸
Pfizer Investigational Site, Miami, Florida, United States

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Bosutinib
Drug: Letrozole

First Posted Date: 2009-04-13

Last Posted Date: 2021-09-27

Lead Sponsor: Pfizer

Target Recruit Count: 16

Registration Number: NCT00880009

Locations: 🇭🇺
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly, Budapest, Hungary
🇺🇸
American Institute of Research, Whittier, California, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 8 locations

Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

Phase 2

Terminated

Conditions: Advanced Breast Cancer

Interventions: Drug: Bosutinib
Drug: Exemestane

First Posted Date: 2008-11-19

Last Posted Date: 2012-11-04

Lead Sponsor: Pfizer

Target Recruit Count: 42

Registration Number: NCT00793546

Locations: Pfizer Investigational Site

Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

Phase 1

Completed

Conditions: Breast Cancer
Leukemia, Myeloid, Chronic

Interventions: Drug: Bosutinib

First Posted Date: 2008-09-25

Last Posted Date: 2009-07-16

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Target Recruit Count: 27

Registration Number: NCT00759837

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