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 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

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

Phase 2

Completed

Conditions: Hepatoblastoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Osteosarcoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Malignant Germ Cell Tumor
Recurrent Childhood Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Kidney Neoplasm
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Soft Tissue Sarcoma

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

First Posted Date: 2010-07-01

Last Posted Date: 2020-05-13

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 118

Registration Number: NCT01154816

Locations: 🇺🇸
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
🇺🇸
Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States

and more 102 locations

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

Phase 1

Completed

Conditions: Advanced Solid Tumors
Adenocarcinoma of the Prostate

Interventions: Drug: Alisertib
Drug: Docetaxel

First Posted Date: 2010-03-26

Last Posted Date: 2019-02-15

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 41

Registration Number: NCT01094288

Alisertib (MLN8237) in Participants With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer

Phase 2

Completed

Conditions: Ovarian Carcinoma
Breast Carcinoma
Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: Alisertib
Drug: Paclitaxel

First Posted Date: 2010-03-24

Last Posted Date: 2018-06-04

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 191

Registration Number: NCT01091428

Study of MLN8237 in Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumors

Interventions: Drug: Alisertib

First Posted Date: 2009-08-19

Last Posted Date: 2019-03-12

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 53

Registration Number: NCT00962091

Locations: 🇺🇸
Premiere Oncology, A Medical Corporation, Santa Monica, California, United States

MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

Phase 2

Completed

Conditions: Ovarian Carcinoma

Interventions: Drug: Alisertib

First Posted Date: 2009-03-02

Last Posted Date: 2022-04-08

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 31

Registration Number: NCT00853307

Locations: 🇺🇸
Summit Medical Group, Berkeley Heights, New Jersey, United States

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

Phase 2

Completed

Conditions: High-Grade Myelodysplastic Syndrome
Acute Myelogenous Leukemia

Interventions: Drug: Alisertib

First Posted Date: 2009-01-28

Last Posted Date: 2018-05-11

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 57

Registration Number: NCT00830518

Locations: 🇺🇸
Hematology and Oncology Associates of Northern New Jersey, Morristown, New Jersey, United States

Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Burkitt's Lymphoma
Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component
Diffuse Large B-cell Lymphoma
T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Alisertib

First Posted Date: 2008-12-12

Last Posted Date: 2018-03-27

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 48

Registration Number: NCT00807495

Locations: 🇺🇸
Hematology Oncology Associates, Virtua Memorial Hospital Burlington County, Mount Holly, New Jersey, United States

Study of MLN8237 in Participants With Advanced Hematological Malignancies

Phase 1

Completed

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

Interventions: Drug: Alisertib

First Posted Date: 2008-06-13

Last Posted Date: 2019-05-31

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 58

Registration Number: NCT00697346

A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Participants With Advanced Malignancies

Phase 1

Completed

Conditions: Advanced Malignancies

Interventions: Drug: alisertib

First Posted Date: 2008-04-03

Last Posted Date: 2019-03-15

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 59

Registration Number: NCT00651664

Locations: 🇪🇸
H. Clínico Universitario de Valencia, Valencia, Spain
🇪🇸
Ciutat Sanitaria Vall d'Hebron - Servicio de Oncologia, Barcelona, Spain

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