Therapy Detail

Therapy Name Alisertib
Synonym
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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Alisertib MLN8237 Aurka Inhibitors 23 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown acute myeloid leukemia not applicable Alisertib Phase I Actionable In a Phase I study, Alisertib (MLN8237) treatment after Cytosar-U (cytarabine) and Idarubicin induction resulted in a composite remission rate (complete remission and complete remission with incomplete neutrophil recovery) of 86% (19/22) in patients with acute myeloid leukemia (PMID: 28034990). 28034990
Unknown unknown lung small cell carcinoma not applicable Alisertib Preclinical - Pdx & cell culture Actionable In a preclinical study, Alisertib (MLN8237), alone and in combination with Taxol (paclitaxel), inhibited growth of small cell lung cancer cell (SCLC) lines in culture and inhibited tumor growth in primary human SCLC xenograft models (Mol Cancer Ther 2013;12(11 Suppl):A282). detail...
Unknown unknown lung small cell carcinoma not applicable Alisertib Phase II Actionable In a Phase II trial, treatment with Alisertib (MLN8237) resulted in an objective response in 21% (10/48) of patients with small cell lung cancer (PMID: 25728526). 25728526
Unknown unknown angiosarcoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in partial response in 2 angiosarcoma patients (PMID: 27502708). 27502708
Unknown unknown breast cancer not applicable Alisertib Preclinical - Cell culture Actionable In a preclinical study, Alisertib (MLN8237) disrupted cell cycle progression and inhibited growth of breast cancer cell lines, with preferential inhibition of aromatase inhibitor-resistant cell lines (PMID: 25667100). 25667100
Unknown unknown breast cancer not applicable Alisertib Preclinical - Pdx & cell culture Actionable In a preclinical study, treatment with Alisertib (MLN8237) resulted in reduced cell migration of breast cancer cells in cell motility assays and in patient derived xenograft (PDX) models of breast cancer, improved survival and reduced metastasis was observed (PMID: 27235164). 27235164
Unknown unknown non-small cell lung carcinoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) demonstrated safety and some anti-tumor activity across a range of advanced solid tumor types, with an objective response rate of 4% (1/23) in patients with non-small cell lung cancer (PMID: 25728526). 25728526
Unknown unknown prostate cancer not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment of patients with neuroendocrine prostate cancer (NEPC) or castration-resistant prostate adenocarcinoma (CRPAC) resulted in a 6-month radiological progression-free survival (PFS) of 13.4% (8/60, 16.7% of NEPC, 5.3% of CRPAC), a median PFS of 2.2 months (2.3 months in NEPC, 2.0 months in CRPAC), and an overall survival of 9.5 months, and 30% (18/60) of patients had stable disease at the third treatment cycle (PMID: 30232224; NCT30232224). 30232224
Unknown unknown Advanced Solid Tumor not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) demonstrated safety and some anti-tumor activity across a range of advanced solid tumor types (PMID: 25728526). 25728526
Unknown unknown glioblastoma multiforme not applicable Alisertib Preclinical Actionable In a preclinical study, Alisertib (MLN8237) decreased proliferation of primary glioblastoma cell lines in culture, and improved survival of primary glioblastoma cell line xenograft models, including models resistant to Avastin (bevacizumab) (PMID: 27816996). 27816996
Unknown unknown ovarian cancer not applicable Alisertib Phase II Actionable In a Phase II clinical trial, Alisertib (MLN8237) demonstrated some preliminary efficacy in patients with platinum-resistant or refractory ovarian cancer, with 10% (3/31) of patients demonstrating objective response and 52% (16/31) of patients achieving stable disease (PMID: 22772063). 22772063
Unknown unknown chondrosarcoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in partial response in a dedifferentiated chondrosarcoma patient (PMID: 27502708). 27502708
Unknown unknown leiomyosarcoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in twelve-week progression free survival in 44% (4/9) of leiomyosarcoma patients (PMID: 27502708). 27502708
Unknown unknown malignant peripheral nerve sheath tumor not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in twelve-week progression free survival in 60% (6/10) of malignant peripheral nerve sheath tumor patients (PMID: 27502708). 27502708
Unknown unknown melanoma not applicable Alisertib Preclinical - Pdx & cell culture Actionable In a preclinical study, Alisertib (MLN8237) impaired mitosis, induced senescence and blocked growth in xenograft models of patient-derived and cell line-derived melanoma tumors (PMID: 23180582). 23180582
Unknown unknown B-cell lymphoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in significant toxicity and an objective response rate of 15% (2/13) in patients with B-cell non Hodgkin's lymphoma (PMID: 28278718). 28278718
Unknown unknown liposarcoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in twelve-week progression free survival in 73% (9/12) of liposarcoma patients (PMID: 27502708). 27502708
Unknown unknown sarcoma not applicable Alisertib Phase II Actionable In a Phase II trial, Alisertib (MLN8237) treatment resulted in twelve-week progression free survival in 36% (4/11) of undifferentiated sarcoma patients (PMID: 27502708). 27502708
Clinical Trial Phase Therapies Title Recruitment Status
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
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
NCT02530619 Phase I Alisertib Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia Active, not recruiting
NCT02319018 Phase I Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Alisertib Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors Completed
NCT02860000 Phase II Alisertib + Fulvestrant Alisertib Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer Recruiting
NCT02700022 Phase I Alisertib Cyclophosphamide + Doxorubicin + Etoposide + Methylprednisolone + Rituximab + Vincristine A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas Terminated
NCT01898078 Phase I Alisertib Food Effect Study of Alisertib (MLN8237) in Patients With Advanced Solid Tumors or Lymphomas Unknown status
NCT02560025 Phase II Alisertib Daunorubicin Idarubicin Cytarabine Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML Active, not recruiting
NCT02293005 Phase II Alisertib Alisertib in Malignant Mesothelioma Active, not recruiting
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
NCT02214147 Phase I Alisertib Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function Completed
NCT02114229 Phase II Cisplatin + Cyclophosphamide + Methotrexate + Vincristine Alisertib Alisertib + Carboplatin + Cyclophosphamide + Vincristine Cyclophosphamide + Topotecan Alisertib + Carboplatin + Cyclophosphamide + Etoposide Carboplatin + Cyclophosphamide + Methotrexate + Vincristine Alisertib + Cisplatin + Cyclophosphamide + Vincristine Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors (SJATRT) Recruiting
NCT02186509 Phase I Alisertib Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas Completed
NCT01799278 Phase II Alisertib A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer Completed
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
NCT02551055 Phase I Docetaxel Paclitaxel Alisertib TAK-659 MLN1117 MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma Terminated
NCT01897012 Phase I Romidepsin Alisertib Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas Completed
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 Unknown status
NCT01848067 Phase Ib/II Abiraterone Prednisone Alisertib Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer Completed