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

Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer
Solid Tumors

Interventions: Drug: Alisertib
Drug: MLN0128

First Posted Date: 2016-03-25

Last Posted Date: 2022-07-25

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 47

Registration Number: NCT02719691

Locations: 🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States

Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors

Phase 1

Completed

Conditions: Malignant Digestive System Neoplasm

Interventions: Drug: Alisertib
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Oxaliplatin

First Posted Date: 2014-12-18

Last Posted Date: 2018-10-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT02319018

Locations: 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States

and more 2 locations

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas

Phase 1

Completed

Conditions: Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Refractory Mantle Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Follicular Lymphoma
Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Recurrent Burkitt Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis
Drug: Romidepsin

First Posted Date: 2013-07-11

Last Posted Date: 2019-01-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 26

Registration Number: NCT01897012

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, 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

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

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

Phase 2

Completed

Conditions: Hepatosplenic T-Cell Lymphoma
Recurrent Adult T-Cell Leukemia/Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-Cell Lymphoma
Recurrent Adult Non-Hodgkin Lymphoma
Adult Nasal Type Extranodal NK/T-Cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

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

First Posted Date: 2011-11-08

Last Posted Date: 2016-03-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 42

Registration Number: NCT01466881

Locations: 🇺🇸
Loyola University Medical Center, Maywood, Illinois, United States
🇺🇸
United Hospital, Saint Paul, Minnesota, United States
🇺🇸
Sparrow Hospital, Lansing, Michigan, United States

and more 158 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy