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

Phase 1

Completed

Conditions: Adult Brain Stem Glioma
Adult Diffuse Astrocytoma
Adult Giant Cell Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Anaplastic Astrocytoma
Adult Glioblastoma
Adult Subependymal Giant Cell Astrocytoma
Recurrent Adult Brain Tumor
Adult Anaplastic Ependymoma

Interventions: Radiation: Hyperfractionated radiation therapy
Radiation: Stereotactic radiosurgery
Drug: Alisertib
Procedure: Quality-of-life assessment

First Posted Date: 2014-07-10

Last Posted Date: 2023-09-07

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 17

Registration Number: NCT02186509

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors

Phase 2

Active, not recruiting

Conditions: Atypical Teratoid Rhabdoid Tumor
Malignant Rhabdoid Tumor

Interventions: Drug: alisertib
Procedure: Surgical resection
Drug: methotrexate
Drug: cisplatin
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: topotecan
Drug: vincristine
Radiation: Radiation therapy

First Posted Date: 2014-04-15

Last Posted Date: 2024-10-31

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 125

Registration Number: NCT02114229

Locations: 🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
Lucille Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States

and more 6 locations

Alisertib in Chemotherapy-pretreated Urothelial Cancer

Phase 2

Completed

Conditions: Transitional Cell Carcinoma
Bladder Cancer

Interventions: Drug: Paclitaxel
Drug: Alisertib
Drug: Placebo

First Posted Date: 2014-04-09

Last Posted Date: 2019-04-11

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 22

Registration Number: NCT02109328

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Mi, Italy

Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Phase 2

Completed

Conditions: Small Cell Lung Cancer

Interventions: Drug: Placebo
Drug: Alisertib
Drug: Paclitaxel

First Posted Date: 2014-01-16

Last Posted Date: 2018-12-27

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 178

Registration Number: NCT02038647

Alisertib and Gemcitabine Hydrochloride in Treating Patients With Solid Tumors or Pancreatic Cancer

Phase 1

Completed

Conditions: Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Acinar Cell Adenocarcinoma of the Pancreas

Interventions: Drug: alisertib
Drug: gemcitabine

First Posted Date: 2013-08-16

Last Posted Date: 2022-08-02

Lead Sponsor: Edward Kim

Target Recruit Count: 26

Registration Number: NCT01924260

Locations: 🇺🇸
UC Davis Comprehensive Cancer Center, Sacramento, California, United States

Irinotecan and Alisertib in Treating Patients With Advanced Solid Tumors or Colorectal Cancer

Phase 1

Completed

Conditions: Recurrent Rectal Cancer
Signet Ring Adenocarcinoma of the Colon
Signet Ring Adenocarcinoma of the Rectum
Unspecified Adult Solid Tumor, Protocol Specific
Recurrent Colon Cancer
Mucinous Adenocarcinoma of the Colon
Mucinous Adenocarcinoma of the Rectum
Stage IIIA Colon Cancer

Interventions: Drug: irinotecan hydrochloride
Drug: alisertib

First Posted Date: 2013-08-15

Last Posted Date: 2019-01-04

Lead Sponsor: University of California, Davis

Target Recruit Count: 17

Registration Number: NCT01923337

Locations: 🇺🇸
UC Davis Comprehensive Cancer Center, Sacramento, California, United States

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

Phase 1

Completed

Conditions: Advanced Solid Tumors
Lymphoma

Interventions: Drug: Alisertib

First Posted Date: 2013-07-12

Last Posted Date: 2019-06-21

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 26

Registration Number: NCT01898078

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, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

Phase 1

Completed

Conditions: Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Adenocarcinoma of the Prostate

Interventions: Drug: Alisertib
Drug: Abiraterone acetate
Drug: Prednisone

First Posted Date: 2013-05-07

Last Posted Date: 2017-12-06

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 9

Registration Number: NCT01848067

Locations: 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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

Phase 1

Completed

Conditions: Lymphoma
Solid Tumors

Interventions: Drug: Alisertib
Drug: Rifampin
Drug: Esomeprazole

First Posted Date: 2013-05-01

Last Posted Date: 2019-03-25

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 55

Registration Number: NCT01844583

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