Therapy Detail

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Therapy Name Alisertib
Synonyms
Therapy Description

Alisertib (MLN8237) binds to and inhibits Aurora A kinase, which may result in disruption of the assembly of the mitotic spindle apparatus, disruption of chromosome segregation, and inhibition of cell proliferation (PMID: 26999067, PMID: 32414750).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Alisertib MLN8237 Aurka Inhibitors 27 Alisertib (MLN8237) binds to and inhibits Aurora A kinase, which may result in disruption of the assembly of the mitotic spindle apparatus, disruption of chromosome segregation, and inhibition of cell proliferation (PMID: 26999067, PMID: 32414750).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RB1 del SMARCB1 loss rhabdoid cancer sensitive Alisertib Preclinical - Cell culture Actionable In a preclinical study, Alisertib (MLN8237) inhibited viability of a SMARCB1-deficient rhabdoid cancer cell line with a deletion of RB1 in culture (PMID: 38315003). 38315003
SMARCA4 inact mut lung non-small cell carcinoma sensitive Alisertib Preclinical - Cell culture Actionable In a preclinical study, a non-small cell lung cancer cell line harboring an inactivating mutation in SMARCA4 demonstrated sensitivity to Alisertib (MLN8237) in culture (PMID: 28102363). 28102363

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02219789 Phase I Fulvestrant Alisertib Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery Completed USA 0
NCT02038647 Phase II Paclitaxel Alisertib Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC) Completed USA | POL | ITA | HUN | FRA | ESP | DEU | CZE | CAN | BEL 0
NCT01848067 Phase Ib/II Abiraterone Prednisone Alisertib Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer Completed USA 0
NCT01898078 Phase I Alisertib Food Effect Study of Alisertib (MLN8237) in Patients With Advanced Solid Tumors or Lymphomas Completed USA 0
NCT02860000 Phase II Alisertib + Fulvestrant Alisertib Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer Active, not recruiting USA 0
NCT01799278 Phase II Alisertib A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer Completed USA 0
NCT01844583 Phase I Alisertib + Esomeprazole Alisertib + Rifampin Alisertib Safety, Tolerability and PK of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib Completed USA 0
NCT02293005 Phase II Alisertib Alisertib in Malignant Mesothelioma Completed USA 0
NCT01471964 Phase Ib/II Erlotinib Alisertib Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer Terminated USA 0
NCT02186509 Phase I Alisertib Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas Completed USA 0
NCT02560025 Phase II Alisertib Daunorubicin Idarubicin Cytarabine Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML Completed USA 0
NCT02214147 Phase I Alisertib Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function Completed USA 0
NCT02319018 Phase I Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Alisertib Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors Completed USA 0
NCT02551055 Phase I Docetaxel Paclitaxel Alisertib Mivavotinib Serabelisib MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma Terminated USA | ESP 0
NCT01897012 Phase I Romidepsin Alisertib Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas Completed USA 0
NCT02259010 Phase I Alisertib Itraconazole A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma Completed USA 0
NCT02114229 Phase II Cisplatin + Cyclophosphamide + Methotrexate + Vincristine Sulfate Alisertib Alisertib + Carboplatin + Cyclophosphamide + Vincristine Sulfate Cyclophosphamide + Topotecan Alisertib + Carboplatin + Cyclophosphamide + Etoposide Carboplatin + Cyclophosphamide + Methotrexate + Vincristine Sulfate Alisertib + Cisplatin + Cyclophosphamide + Vincristine Sulfate Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors (SJATRT) Active, not recruiting USA 0
NCT02530619 Phase I Alisertib Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia Unknown status USA 0
NCT06095505 Phase II Alisertib A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer Recruiting USA 0
NCT02700022 Phase I Alisertib Cyclophosphamide + Doxorubicin + Etoposide + Methylprednisolone + Rituximab + Vincristine Sulfate A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas Terminated USA 0


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