Drugs / Alisertib
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Alisertib

Small molecule targets AURKA via inhibition

Developed for
cancer · mantle cell lymphoma · Burkitt lymphoma · diffuse large B-cell lymphoma · lymphoma · small cell lung carcinoma · acute myeloid leukemia · anaplastic large cell lymphoma
+103 more · angioimmunoblastic T-cell lymphoma · breast cancer · digestive system cancer · follicular lymphoma · head and neck squamous cell carcinoma · neuroblastoma · non-small cell lung carcinoma · Waldenstrom macroglobulinemia · adenocarcinoma · adult T-cell leukemia/lymphoma · breast carcinoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · female breast carcinoma · hepatosplenic T-cell lymphoma · Hodgkins lymphoma · hormone receptor-positive breast cancer · lung cancer · MALT lymphoma · nodal marginal zone B-cell lymphoma · ovarian carcinoma · peripheral T-cell lymphoma, not otherwise specified · plasma cell myeloma · prostate adenocarcinoma · splenic marginal zone lymphoma · acute megakaryoblastic leukemia · adult anaplastic ependymoma · adult brainstem glioma · adult glioblastoma · adult oligodendroglioma · anaplastic astrocytoma · anaplastic oligodendroglioma · atypical teratoid rhabdoid tumor · B-cell adult acute lymphocytic leukemia · central nervous system cancer · childhood acute lymphoblastic leukemia · childhood acute myeloid leukemia · childhood kidney neoplasm · childhood malignant neoplasm · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · diffuse astrocytoma · enteropathy-associated T-cell lymphoma · estrogen-receptor positive breast cancer · Ewing sarcoma/peripheral primitive neuroectodermal tumor · extranodal nasal NK/T cell lymphoma · fallopian tube cancer · female reproductive organ cancer · gastroesophageal adenocarcinoma · giant cell glioblastoma · gliosarcoma · grade III lymphomatoid granulomatosis · hairy cell leukemia · head and neck cancer · head and neck neoplasm · hepatoblastoma · Her2-receptor negative breast cancer · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · hormone-resistant prostate carcinoma · intraocular lymphoma · invasive breast carcinoma · large-cell immunoblastic lymphoma · leiomyosarcoma · leiomyosarcoma of the corpus uteri · liposarcoma · male reproductive organ cancer · malignant childhood germ cell neoplasm · malignant peripheral nerve sheath tumor · malignant urinary system neoplasm · marginal zone lymphoma · mature T-cell and NK-cell non-Hodgkin lymphoma · melanoma · mesothelioma · metastatic melanoma · mycosis fungoides and variants · myelodysplastic syndrome · myelofibrosis · myxofibrosarcoma · neoplasm · neoplastic disease or syndrome · osteosarcoma · ovarian cancer · pancreatic acinar cell carcinoma · pancreatic ductal adenocarcinoma · pancreatic neoplasm · peritoneum cancer · pilocytic astrocytoma · pineal gland astrocytoma · primary cutaneous B-cell lymphoma · primary myelofibrosis · progesterone-receptor positive breast cancer · prostate small cell carcinoma · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · rhabdomyosarcoma · small intestine lymphoma · subependymal giant cell astrocytoma · T-cell adult acute lymphocytic leukemia · T-cell large granular lymphocyte leukemia · T-cell non-Hodgkin lymphoma · testicular lymphoma · transitional cell carcinoma · undifferentiated pleomorphic sarcoma · urinary bladder cancer
Investigated by
Millennium Pharmaceuticals, Inc. · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · Puma Biotechnology, Inc. · Mayo Clinic · Children's Oncology Group
+25 more · Massachusetts General Hospital · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Takeda · Abramson Cancer Center at Penn Medicine · Collin Blakely · Edward Kim · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fox Chase Cancer Center · Millennium: The Takeda Oncology Company · NRG Oncology · New Approaches to Neuroblastoma Therapy Consortium · Northwestern University · Ohio State University Comprehensive Cancer Center · St. Jude Children's Research Hospital · Takeda Pharmaceuticals U.S.A., Inc. · The Leukemia and Lymphoma Society · UNC Lineberger Comprehensive Cancer Center · US Oncology Research · University of California, Davis · University of Colorado, Denver · University of Illinois at Chicago · University of Wisconsin, Madison · Vanderbilt-Ingram Cancer Center · Washington University School of Medicine · Weill Medical College of Cornell University

Trials 64 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 133 trials
Phase 1 NCT04479306 Jun 2020 → Jul 2023 non-small cell lung carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT04085315 Nov 2019 → Dec 2026 expected lung cancer Collin Blakely Recruiting No outcome recorded
Phase 1 NCT02700022 Oct → Nov 2016 Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma UNC Lineberger Comprehensive Cancer Center Terminated No outcome recorded Stop: Business
Phase 1 NCT02812056 Sep 2016 → Sep 2021 digestive system cancer, female reproductive organ cancer, head and neck cancer, male reproductive organ cancer M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT02719691 May 2016 → Mar 2020 breast cancer University of Colorado, Denver Completed No outcome recorded
Phase 1 NCT02551055 Oct 2015 → Feb 2017 adenocarcinoma Millennium Pharmaceuticals, Inc. Terminated No outcome recorded Stop: Business
Phase 1 NCT02319018 Aug 2015 → Sep 2018 digestive system cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT02367352 Mar 2015 → May 2017 ovarian cancer, small cell lung carcinoma Millennium Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1 NCT02186509 Jan 2015 → Mar 2017 adult anaplastic ependymoma, adult brainstem glioma, adult glioblastoma, adult oligodendroglioma +8 Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 1 NCT02327169 Jan 2015 → Jul 2018 neoplastic disease or syndrome Millennium Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT04555837 Sep 2020 → Apr 2025 head and neck squamous cell carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/2 NCT01848067 Aug 2013 → Mar 2015 hormone-resistant prostate carcinoma, prostate adenocarcinoma Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 1/2 NCT01601535 May 2012 → Jul 2018 neuroblastoma New Approaches to Neuroblastoma Therapy Consortium Completed No outcome recorded
Phase 1/2 NCT01471964 Oct 2011 → Feb 2017 non-small cell lung carcinoma Fox Chase Cancer Center Terminated No outcome recorded
Phase 1/2 NCT01397825 Aug 2011 → Feb 2015 Burkitt lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma Millennium Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/2 NCT01034553 Feb 2010 → Sep 2014 plasma cell myeloma Mayo Clinic Completed No outcome recorded
Phase 1/2 NCT01045421 Feb 2010 → May 2013 breast cancer, gastroesophageal adenocarcinoma, head and neck squamous cell carcinoma, non-small cell lung carcinoma +1 Millennium Pharmaceuticals, Inc. Completed No outcome recorded
Phase 222 trials · 1 met primary · 5 missed
Phase 2 NCT07706179 Oct 2026 → Sep 2028 expected hormone receptor-positive breast cancer University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 2 NCT07465757 Sep 2026 → Mar 2028 expected small cell lung carcinoma Puma Biotechnology, Inc. Recruiting No outcome recorded
Phase 2 NCT06369285 Nov 2024 → Dec 2027 expected hormone receptor-positive breast cancer Puma Biotechnology, Inc. Recruiting No outcome recorded
Phase 2 NCT06095505 Feb 2024 → Oct 2027 expected small cell lung carcinoma Puma Biotechnology, Inc. Recruiting No outcome recorded
Phase 2 NCT02860000 Jul 2017 → Jan 2022 Her2-receptor negative breast cancer, female breast carcinoma, invasive breast carcinoma Mayo Clinic Completed Missed primary
Phase 2 NCT02560025 Dec 2015 → Oct 2017 acute myeloid leukemia Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT02293005 May 2015 → Jul 2021 lung cancer, mesothelioma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT02187991 Feb 2015 → Apr 2024 breast carcinoma US Oncology Research Completed Met primary
Phase 2 NCT02109328 Aug 2014 → Jul 2015 transitional cell carcinoma, urinary bladder cancer Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Completed Missed primary
Phase 2 NCT02114229 May 2014 → Sep 2025 overdue atypical teratoid rhabdoid tumor St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 31 trial · 1 missed
Phase 3 NCT01482962 Jun 2012 → Jun 2015 peripheral T-cell lymphoma, not otherwise specified Millennium Pharmaceuticals, Inc. Completed Missed primary
Phase not applicable1 trial
— NCT02530619 Oct 2015 → May 2018 acute megakaryoblastic leukemia, myelofibrosis, primary myelofibrosis Northwestern University Unknown No outcome recorded
Comparator or background therapy1 trial
— NCT03005262 Background — prostate cancer The University of Texas Health Science Center at San Antonio No longer available No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2024-06-03 Puma Biotechnology, Inc. Results Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer pumabiotechnology.com ↗
Intermittent alisertib 30 mg BID was identified as the MTD and RP2D in combination with osimertinib 80 mg daily.
2024-06-02 Puma Biotechnology, Inc. Results Puma Biotechnology Announces Presentation of Findings from a Phase II Study of Alisertib in Endocrine-Resistant Metastatic Breast Cancer (TBCRC 041) pumabiotechnology.com ↗
2023-09-21 Puma Biotechnology, Inc. Regulatory Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer pumabiotechnology.com ↗
“Obtaining Orphan Drug Designation from the FDA signifies our continued progress and commitment to the development of alisertib for the treatment of small cell lung cancer,” said Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma.
2023-08-08 Puma Biotechnology, Inc. Regulatory Puma Biotechnology Announces FDA Clearance of IND for Alisertib in Small Cell Lung Cancer pumabiotechnology.com ↗
Puma can proceed with the clinical development of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (SCLC).
2023-03-14 Puma Biotechnology, Inc. Results Puma Biotechnology Announces Publication of Phase II Clinical Trial of Alisertib in JAMA Oncology pumabiotechnology.com ↗
The efficacy results from the trial showed that for the 46 evaluable patients in the alisertib alone arm of the trial nine partial responses were seen, resulting in an overall response rate of 19.6%.
2015-05-13 Takeda Results Takeda Announces Termination of Alisertib Phase 3 Trial in Relapsed or Refractory Peripheral T-cell Lymphoma takeda.com ↗
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it has decided to discontinue the Phase 3 trial of alisertib (MLN8237) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 68 sources stand behind the page.

FieldValueCited text
Known as alisertib “MLN8237 Aurora A kinase inhibitor, alisertib” NCT01471964 ↗
56

NCT01714947 ↗

NCT00651664 ↗

NCT01924260 ↗

NCT02293005 ↗

NCT04479306 ↗

NCT02114229 ↗

NCT01482962 ↗

NCT07706179 ↗

NCT01639911 ↗

NCT01923337 ↗

Show 46 more sources

Known as ALISERTIB (MLN8237) ChEMBL registry synonym — accepted as the source's own label CHEMBL483158 ↗
Known as ALISERTIB SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL483158 ↗
Known as CHEMBL483158 ChEMBL registry synonym — accepted as the source's own label CHEMBL483158 ↗
Known as MLN-8237-004 ChEMBL registry synonym — accepted as the source's own label CHEMBL483158 ↗
Known as MLN8237 “A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion...” NCT02719691 ↗
12

“BACKGROUND: This phase 1b study evaluated an enteric-coated tablet (ECT) formulation of the investigational Aurora A kinase inhibitor, alisertib (MLN8237).” PMID 24879333 ↗ Jun 2014

“Alisertib (MLN8237) will be supplied in capsules of 5 or 25 mg” NCT00500903 ↗

“Alisertib (MLN8237) enteric coated tablet (ECT).” NCT01397825 ↗

“Aurora A kinase inhibitor MLN8237” NCT01316692 ↗

NCT02444884 ↗

NCT01799278 ↗

NCT03005262 ↗

NCT01471964 ↗

NCT01034553 ↗

NCT01601535 ↗

Show 2 more sources

Action Inhibit “a Novel Aurora A Kinase Inhibitor” NCT00500903 ↗
Modality Small molecule “Alisertib (MLN8237) is an investigational, oral, small-molecule, selective inhibitor of Aurora A kinase.” PMID 26073352 ↗ Jul 2015
Route Oral “Each dose will be given by mouth with 8 ounces of water” NCT00500903 ↗
Target AURKA “AURKA inhibitor, MLN8237” NCT01316692 ↗