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ClinicalTrials.gov public records Last synced Sep 30, 2026, 5:08 PM EDT

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Showing 25–48 of 58 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Alisertib (MLN8237) Clear all
Completed Phase 1Phase 2 Interventional Results available

MLN8237 in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab +/- Vincristine

NCT01397825
View directory record Official record
Conditions
Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt's Lymphoma
Interventions
Alisertib (MLN8237), Rituximab, Vincristine
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
15
States / cities
Tucson, Arizona • Beverly Hills, California • Burbank, California + 12 more
Source: ClinicalTrials.gov public record
Updated Mar 27, 2018 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 2 Interventional Results available

Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma

NCT02293005
View directory record Official record
Conditions
Lung Cancer, Mesothelioma
Interventions
Alisertib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 4, 2022 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 2 Interventional Results available

Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

NCT02860000
View directory record Official record
Conditions
Estrogen Receptor Status, HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Interventions
Alisertib, Fulvestrant, Laboratory Biomarker Analysis
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Female only
Enrollment
96 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2025
U.S. locations
8
States / cities
Washington D.C., District of Columbia • Boston, Massachusetts • Ann Arbor, Michigan + 5 more
Source: ClinicalTrials.gov public record
Updated Sep 24, 2026 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer

NCT04555837
View directory record Official record
Conditions
Head and Neck Squamous Cell Carcinoma, Malignant Solid Neoplasm
Interventions
Alisertib, Pembrolizumab
Drug · Biological
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 20, 2025 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

NCT02259010
View directory record Official record
Conditions
Advanced Solid Tumors, Relapsed/Refractory Lymphoma
Interventions
Alisertib, Itraconazole
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
4
States / cities
St Louis, Missouri • Oklahoma City, Oklahoma • Germantown, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 20, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function

NCT02214147
View directory record Official record
Conditions
Advanced Solid Tumors, Relapsed/Refractory Lymphoma
Interventions
Alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
7
States / cities
Miami, Florida • Chicago, Illinois • Ann Arbor, Michigan + 4 more
Source: ClinicalTrials.gov public record
Updated Nov 15, 2018 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT01034553
View directory record Official record
Conditions
Refractory Multiple Myeloma
Interventions
Aurora A kinase inhibitor MLN8237, bortezomib
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
6
States / cities
Scottsdale, Arizona • San Francisco, California • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated May 25, 2016 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional

Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

NCT02219789
View directory record Official record
Conditions
Estrogen Receptor Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Interventions
Alisertib, Fulvestrant, Laboratory Biomarker Analysis
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 3, 2018 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors

NCT00500903
View directory record Official record
Conditions
Advanced Malignancies
Interventions
Alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
87 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Mar 14, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 2 Interventional Results available

Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

NCT01154816
View directory record Official record
Conditions
Hepatoblastoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Kidney Neoplasm, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma
Interventions
Alisertib, Laboratory Biomarker Analysis, Pharmacological Study
Drug · Other
Lead sponsor
Children's Oncology Group
Network
Eligibility
1 Year to 21 Years
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2019
U.S. locations
97
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Downey, California + 78 more
Source: ClinicalTrials.gov public record
Updated May 13, 2020 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas

NCT02186509
View directory record Official record
Conditions
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Recurrent Adult Brain Tumor
Interventions
Hyperfractionated radiation therapy, Stereotactic radiosurgery, Alisertib, Quality-of-life assessment
Radiation · Drug · Procedure
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 30, 2025 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Study of MLN8237 in Participants With Advanced Hematological Malignancies

NCT00697346
View directory record Official record
Conditions
B-cell Follicular Lymphoma, B-cell Marginal Zone Lymphoma, Diffuse Large B-cell Lymphoma, B-cell Mantle Cell Lymphoma, B-cell Small Lymphocytic Lymphoma, B-Cell Chronic Lymphocytic Leukemia, Multiple Myeloma, Waldenstrom's Macroglobulinemia, Noncutaneous Peripheral T-cell Lymphoma Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Enteropathy Associated T-cell Lymphoma, NK Lymphoma
Interventions
Alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2016
U.S. locations
10
States / cities
Scottsdale, Arizona • Lexington, Kentucky • Baltimore, Maryland + 7 more
Source: ClinicalTrials.gov public record
Updated May 31, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 2 Interventional Results available

A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

NCT01799278
View directory record Official record
Conditions
Small Cell Prostate Cancer, Neuroendocrine Prostate Cancer, Prostate Adenocarcinoma Plus > 50% Immunohistochemical Staining for Neuroendocrine Markers
Interventions
MLN8237
Drug
Lead sponsor
Weill Medical College of Cornell University
Other
Eligibility
18 Years and older · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
8
States / cities
Chicago, Illinois • Detroit, Michigan • New Brunswick, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Jan 23, 2018 · Synced Sep 30, 2026, 5:08 PM EDT
Terminated Phase 2 Interventional Results available

Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma

NCT01316692
View directory record Official record
Conditions
Recurrent Melanoma, Stage IIIc Melanoma, Stage IV Melanoma
Interventions
laboratory biomarker identification and analysis, biopsy, immunohistochemistry/tissue microarrays, TdT-mediated dUTP nick end labeling assay, mass spectrometry
Other · Procedure · Genetic
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated May 30, 2016 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Study of MLN8237 in Participants With Advanced Solid Tumors

NCT00962091
View directory record Official record
Conditions
Advanced Solid Tumors
Interventions
Alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2014
U.S. locations
1
States / cities
Santa Monica, California
Source: ClinicalTrials.gov public record
Updated Mar 12, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Withdrawn Phase 1 Interventional

Alsertib (MLN8237) and Brentuximab Vedotin for Relapsed/Refractory CD30-Positive Lymphomas and Solid Malignancies

NCT02780011
View directory record Official record
Conditions
CD30-positive Lymphoma, CD30-positive Solid Tumor
Interventions
Brentuximab Vedotin, Alsertib
Drug
Lead sponsor
Eric Bernicker, MD
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 27, 2018 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

NCT01094288
View directory record Official record
Conditions
Advanced Solid Tumors, Adenocarcinoma of the Prostate
Interventions
Alisertib, Docetaxel
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2017
U.S. locations
4
States / cities
Indianapolis, Indiana • Portland, Oregon • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 15, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas

NCT01898078
View directory record Official record
Conditions
Advanced Solid Tumors, Lymphoma
Interventions
Alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
3
States / cities
The Bronx, New York • Nashville, Tennessee • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jun 21, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

NCT01844583
View directory record Official record
Conditions
Solid Tumors, Lymphoma
Interventions
Alisertib, Esomeprazole, Rifampin
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
55 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
7
States / cities
Sarasota, Florida • St Louis, Missouri • Oklahoma City, Oklahoma + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2019 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome

NCT00830518
View directory record Official record
Conditions
Acute Myelogenous Leukemia, High-Grade Myelodysplastic Syndrome
Interventions
Alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Morristown, New Jersey
Source: ClinicalTrials.gov public record
Updated May 11, 2018 · Synced Sep 30, 2026, 5:08 PM EDT
Active, not recruiting Phase 2 Interventional

Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors

NCT02114229
View directory record Official record
Conditions
Malignant Rhabdoid Tumor, Atypical Teratoid Rhabdoid Tumor
Interventions
alisertib, methotrexate, cisplatin, carboplatin, cyclophosphamide, etoposide, topotecan, vincristine, Surgical resection, Radiation therapy
Drug · Procedure · Radiation
Lead sponsor
St. Jude Children's Research Hospital
Other
Eligibility
Up to 21 Years
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2027
U.S. locations
9
States / cities
Palo Alto, California • San Diego, California • Aurora, Colorado + 6 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 2 Interventional Results available

Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML

NCT02560025
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Alisertib, Cytarabine, Idarubicin, Daunorubicin
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 5, 2020 · Synced Sep 30, 2026, 5:08 PM EDT
Not yet recruiting Phase 2 Interventional

Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer

NCT07706179
View directory record Official record
Conditions
HR+/HER2+ Breast Cancer, Metastatic Breast Cancer
Interventions
Alisertib
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Sep 30, 2026, 5:08 PM EDT
Completed Phase 1 Interventional Results available

Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

NCT01714947
View directory record Official record
Conditions
Advanced Solid Tumors, Lymphoma
Interventions
[^14C]-alisertib, alisertib
Drug
Lead sponsor
Millennium Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
1
States / cities
Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated Oct 31, 2018 · Synced Sep 30, 2026, 5:08 PM EDT