Therapy Detail

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Therapy Name Bosutinib
Synonyms
Therapy Description

Bosulif (bosutinib) inhibits SRC and ABL kinases, and has additional activity against other kinases including AXL, TNK2, BTK, resulting in decreased pathway activation and inhibition of tumor cell proliferation (PMID: 12543790, PMID: 19039322, PMID: 26555154). Bosulif (bosutinib) is FDA approved for use in patients with Ph+ (BCR-ABL) chronic myelogenous leukemia (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Bosutinib Bosulif SKI-606|PF-5208763 ABL Inhibitor (pan) 8 AXL Inhibitor 27 BTK inhibitor 24 SRC Inhibitor 29 TNK2 Inhibitor 6 Bosulif (bosutinib) inhibits SRC and ABL kinases, and has additional activity against other kinases including AXL, TNK2, BTK, resulting in decreased pathway activation and inhibition of tumor cell proliferation (PMID: 12543790, PMID: 19039322, PMID: 26555154). Bosulif (bosutinib) is FDA approved for use in patients with Ph+ (BCR-ABL) chronic myelogenous leukemia (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
SRC positive biliary tract cancer sensitive Bosutinib Preclinical - Cell line xenograft Actionable In a preclinical study, Bosulif (bosutinib) inhibited Src signaling, resulted in cell cycle arrest and decreased invasion of biliary tract cancer cell lines in culture, and delayed tumor growth in cell line xenograft models (PMID: 27196758). 27196758
ABL1 rearrange myeloid neoplasm sensitive Bosutinib Guideline Actionable Bosulif (bosutinib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an ABL1 rearrangement (NCCN.org). detail...
SRC positive Advanced Solid Tumor predicted - sensitive Bosutinib Preclinical - Cell culture Actionable In a preclinical study, Bosulif (bosutinib) inhibited invasion and migration of Src-positive cells in culture (PMID: 18483306). 18483306
Unknown unknown Advanced Solid Tumor not applicable Bosutinib Phase I Actionable In a Phase I trial, Bosulif (bosutinib) demonstrated safety and limited efficacy in patients with advanced solid tumors (PMID: 22179664). 22179664
Unknown unknown chronic myeloid leukemia not applicable Bosutinib Clinical Study Actionable In a meta-analysis, Bosulif (bosutinib) treatment was associated with increased rate of major molecular response compared with Gleevec (imatinib) (Odds Ratio (OR): 1.86 [1.29-2.70]), but not improved overall survival (OR: 2.38 [0.82-6.89]), and was associated with a trend toward increased risk of vascular occlusive events in chronic myeloid leukemia patients (PMID: 26847662). 26847662

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04258943 Phase Ib/II Bosutinib Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia", Recruiting USA 0
NCT01331291 Phase II Bosutinib Bosutinib in Adult Patients With Recurrent Glioblastoma Completed USA 0
NCT03106779 Phase III Bosutinib Asciminib Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs Active, not recruiting USA | CAN 23
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting CAN 0
NCT02130557 Phase III Bosutinib Imatinib A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia Completed USA | CAN 24
NCT01903733 Phase I Bosutinib Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008 Active, not recruiting USA | CAN 27
NCT03654768 Phase II Bosutinib Dasatinib Nilotinib Dasatinib + Ruxolitinib Bosutinib + Ruxolitinib Nilotinib + Ruxolitinib Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia Recruiting USA 0
NCT02906696 Phase II Bosutinib Bosutinib Dose-Optimization Study in Chronic Myeloid Leukemia (CML) Terminated USA 0
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Active, not recruiting USA 0
NCT02228382 FDA approved Bosutinib Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors Completed USA 7


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