Alisertib

Generic Name: Alisertib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₀ClFN_₄O_₄

CAS Number: 1028486-01-2

Unique Ingredient Identifier: T66ES73M18

Background: Alisertib is a novel aurora A kinase inhibitor under investigation for the treatment of various forms of cancer.

Indication: For the treatment of various forms of cancer.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Phase 2

Terminated

Conditions: Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Recurrent Grade 3 Follicular Lymphoma

Interventions: Drug: alisertib
Biological: rituximab
Other: laboratory biomarker analysis

First Posted Date: 2013-03-15

Last Posted Date: 2018-06-06

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 14

Registration Number: NCT01812005

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
🇺🇸
Emory University, Atlanta, Georgia, United States

Alisertib for Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Cytarabine
Drug: Idarubicin
Drug: Alisertib

First Posted Date: 2013-01-30

Last Posted Date: 2017-02-17

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 22

Registration Number: NCT01779843

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

Phase 1

Completed

Conditions: Advanced Solid Tumors
Lymphoma

Interventions: Drug: [^14C]-alisertib
Drug: alisertib

First Posted Date: 2012-10-26

Last Posted Date: 2018-10-31

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 3

Registration Number: NCT01714947

Locations: 🇺🇸
Comprehensive Clinical Development, Tacoma, Washington, United States

Alisertib, Bortezomib, and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or B-cell Low Grade Non-Hodgkin Lymphoma

Phase 1

Active, not recruiting

Conditions: Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Alisertib
Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Biological: Rituximab

First Posted Date: 2012-09-28

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT01695941

Locations: 🇺🇸
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
🇺🇸
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
🇺🇸
Montefiore Medical Center - Moses Campus, Bronx, New York, United States

and more 1 locations

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Phase 2

Completed

Conditions: Myxofibrosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Leiomyosarcoma
Recurrent Liposarcoma
Recurrent Malignant Peripheral Nerve Sheath Tumor
Recurrent Undifferentiated Pleomorphic Sarcoma
Stage III Soft Tissue Sarcoma AJCC v7
Stage IV Soft Tissue Sarcoma AJCC v7

Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis

First Posted Date: 2012-07-30

Last Posted Date: 2017-11-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 72

Registration Number: NCT01653028

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Oncology Hematology Care Inc-Mercy West, Cincinnati, Ohio, United States
🇺🇸
Oncology Hematology Care Inc - Anderson, Cincinnati, Ohio, United States

and more 232 locations

Phase I Study of MLN8237 and Pazopanib in Patients With Solid Tumors

Phase 1

Completed

Conditions: Malignant Neoplasm of Gastrointestinal Tract
Genitourinary Neoplasms Malignancy and Gender Unspecified
Head and Neck Neoplasms
Melanoma
Malignant Neoplasm of Thorax
Malignant Neoplasm of Breast
CNS Malignancy

Interventions: Drug: Alisertib
Drug: Pazopanib

First Posted Date: 2012-07-13

Last Posted Date: 2019-07-22

Lead Sponsor: University of Illinois at Chicago

Target Recruit Count: 28

Registration Number: NCT01639911

Locations: 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States

Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Phase 2

Completed

Conditions: Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma

Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis

First Posted Date: 2012-07-11

Last Posted Date: 2019-07-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 23

Registration Number: NCT01637961

Locations: 🇺🇸
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
🇺🇸
Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

and more 47 locations

Alisertib in Combination With Vorinostat in Treating Patients With Relapsed or Recurrent Hodgkin Lymphoma, B-Cell Non-Hodgkin Lymphoma, or Peripheral T-Cell Lymphoma

Phase 1

Completed

Conditions: Adult B Acute Lymphoblastic Leukemia
Adult T Acute Lymphoblastic Leukemia
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-Cell Lymphoma
Intraocular Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Mycosis Fungoides and Sezary Syndrome
Chronic Lymphocytic Leukemia
Hepatosplenic T-Cell Lymphoma

Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Vorinostat

First Posted Date: 2012-03-30

Last Posted Date: 2018-04-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 34

Registration Number: NCT01567709

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 2 locations

A Study of Alisertib (MLN8237) in Adult East Asian Participants With Advanced Solid Tumors or Lymphomas

Phase 1

Completed

Conditions: Advanced Solid Tumors
Lymphomas

Interventions: Drug: Alisertib

First Posted Date: 2012-01-19

Last Posted Date: 2019-03-15

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 36

Registration Number: NCT01512758

Locations: 🇸🇬
National Cancer Centre, Tiong Bahru, Singapore

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Phase 3

Completed

Conditions: Refractory Peripheral T-Cell Lymphoma
Relapsed Peripheral T-Cell Lymphoma

Interventions: Drug: Alisertib
Drug: Pralatrexate
Drug: Gemcitabine
Drug: Romidepsin

First Posted Date: 2011-12-01

Last Posted Date: 2018-07-31

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 271

Registration Number: NCT01482962

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