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, and 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 adult and pediatric patients 1 year of age and older 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) 9 AXL Inhibitor 30 BCR-ABL Inhibitor 32 BTK inhibitor 37 SRC Inhibitor 31 TNK2 Inhibitor 6 | Bosulif (bosutinib) inhibits SRC and ABL kinases and has additional activity against other kinases including AXL, TNK2, and 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 adult and pediatric patients 1 year of age and older 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 |
|---|---|---|---|---|---|---|---|
| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | Completed | USA | 0 |
| NCT04877522 | FDA approved | Asciminib Bosutinib Dasatinib Nilotinib Asciminib + Imatinib | Asciminib Roll-over Study | Recruiting | USA | TUR | ROU | POL | LBN | ITA | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BGR | AUT | ARG | 9 |
| NCT04258943 | Phase Ib/II | Bosutinib | Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid 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 | Terminated | USA | SWE | NOR | ITA | FRA | ESP | DEU | AUT | 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 | TUR | ROU | NLD | LBN | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | AUS | ARG | 6 |
| 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 | SWE | SVK | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUS | 7 |
| 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 | Completed | USA | TUR | POL | NLD | LVA | ITA | HUN | GBR | FRA | FIN | ESP | CAN | BRA | BEL | AUS | ARG | 13 |
| NCT01331291 | Phase II | Bosutinib | Bosutinib in Adult Patients With Recurrent Glioblastoma | Completed | USA | 0 |
| 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 |
| NCT04971226 | Phase III | Asciminib Bosutinib Imatinib Dasatinib Nilotinib | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP | Active, not recruiting | USA | SWE | SVK | NOR | NLD | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BGR | BEL | AUT | AUS | 8 |
| 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 | Active, not recruiting | USA | 0 |
| NCT02906696 | Phase II | Bosutinib | Bosutinib Dose-Optimization Study in Chronic Myeloid Leukemia (CML) | Terminated | USA | 0 |
| NCT03831776 | Phase II | Bosutinib + Ropeginterferon Bosutinib | Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis (BosuPeg) | Recruiting | SWE | NOR | FIN | DNK | 0 |
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