DeepMed Research

Alisertib

Generic Name: Alisertib

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.

Clinical Trials

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Phase 2

Recruiting

Conditions: Metastatic Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: Alisertib
Drug: Endocrine therapy

First Posted Date: 2024-04-16

Last Posted Date: 2025-05-20

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 150

Registration Number: NCT06369285

Locations: 🇪🇸
Fundación Instituto Valenciano de Oncología (IVO), Valencia, Spain
🇺🇸
Alabama Oncology, Birmingham, Alabama, United States
🇺🇸
Mayo Clinic Hospital, Phoenix, Arizona, United States

and more 38 locations

A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Small Cell Lung Cancer

Interventions: Drug: Alisertib

First Posted Date: 2023-10-23

Last Posted Date: 2024-12-16

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 60

Registration Number: NCT06095505

Locations: 🇺🇸
Southern Cancer Center, Daphne, Alabama, United States
🇺🇸
The Oncology Institute of Hope and Innovation, Fort Lauderdale, Florida, United States
🇺🇸
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States

and more 23 locations

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

Phase 1

Completed

Conditions: Head and Neck Squamous Cell Carcinoma
Malignant Solid Neoplasm

Interventions: Drug: Alisertib
Biological: Pembrolizumab

First Posted Date: 2020-09-21

Last Posted Date: 2025-05-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT04555837

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

Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Stage IIIB Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Recurrent Lung Non-Small Cell Carcinoma
Stage IVA Lung Cancer AJCC v8

Interventions: Drug: Alisertib
Drug: Osimertinib
Drug: Sapanisertib

First Posted Date: 2020-07-21

Last Posted Date: 2024-06-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 37

Registration Number: NCT04479306

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

Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

Phase 1

Recruiting

Conditions: Lung Cancer Metastatic
EGFR Gene Mutation

Interventions: Drug: Osimertinib
Drug: Alisertib

First Posted Date: 2019-09-11

Last Posted Date: 2024-06-10

Lead Sponsor: Collin Blakely

Target Recruit Count: 38

Registration Number: NCT04085315

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

MLN8237 for a Subject With Adenocarcinoma of the Prostate

Conditions: Prostate Cancer

First Posted Date: 2016-12-29

Last Posted Date: 2018-04-04

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Registration Number: NCT03005262

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

Phase 2

Active, not recruiting

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: Drug: Alisertib
Other: Laboratory Biomarker Analysis
Drug: Fulvestrant

First Posted Date: 2016-08-09

Last Posted Date: 2024-10-18

Lead Sponsor: Mayo Clinic

Target Recruit Count: 96

Registration Number: NCT02860000

Locations: 🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

and more 5 locations

Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

Phase 1

Withdrawn

Conditions: Malignant Neoplasms of Digestive Organs
Malignant Neoplasms of Female Genital Organs
Malignant Neoplasms of Lip Oral Cavity and Pharynx
Malignant Neoplasms of Male Genital Organs

Interventions: Drug: Alisertib
Drug: TAK-228

First Posted Date: 2016-06-23

Last Posted Date: 2017-03-27

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT02812056

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

Phase 1

Withdrawn

Conditions: CD30-positive Lymphoma
CD30-positive Solid Tumor

Interventions: Drug: Brentuximab Vedotin
Drug: Alsertib

First Posted Date: 2016-05-23

Last Posted Date: 2018-07-27

Lead Sponsor: Eric Bernicker, MD

Registration Number: NCT02780011

Locations: 🇺🇸
Houston Methodist Cancer Center, Houston, Texas, United States

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

Drug Development Updates

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