Enzalutamide

Generic Name: Enzalutamide

Brand Names: Xtandi, Enzalutamide Viatris

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₆F_₄N_₄O_₂S

CAS Number: 915087-33-1

Unique Ingredient Identifier: 93T0T9GKNU

Background: Enzalutamide is an androgen receptor (AR) inhibitor for the treatment of castration-resistant prostate cancer (CRPC), both metastatic and non-metastatic. It is a second-generation antiandrogen agent that the FDA approved on August 31, 2012. Although androgen deprivation therapy (ADT) is the first-line treatment of prostate cancer and remission can be achieved, arising resistance is inevitable, becoming castration-resistant prostate cancer. Until recently, docetaxel is the only treatment available for metastatic CRPC; however, AR inhibitors have been developed for more targeted therapy, although first-generation AR inhibitors like bicalutamide did not substantially increase the survival rate. Second-generation such as enzalutamide is more efficacious due to a higher affinity to AR and no partial agonist activity compared to bicalutamide.

Due to a favorable pharmacological profile, a phase 1 study of enzalutamide was initiated in July 2007. Compared to the average time of 10 to 15 years for a drug to go from pre-clinical to clinical studies, enzalutamide was developed relatively rapidly.

Indication: Enzalutamide is indicated for the treatment of castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (mCRPC). It is also used in combination with talazoparib for the treatment of adult patients with HRR gene-mutated mCRPC.

Associated Conditions: Castration Resistant Prostate Cancer, Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Associated Therapies: -

Clinical Trials

Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide

Not Applicable

Completed

Conditions: Prostate Cancer

Interventions: Drug: Enzalutamide

First Posted Date: 2015-10-27

Last Posted Date: 2022-05-25

Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Target Recruit Count: 60

Registration Number: NCT02588001

Locations: 🇯🇵
The Jikei university school of medicin, Minato-ku, Tokyo, Japan
🇯🇵
Kagawa University Faculty of Medicine, Kita-gun, Kagawa-prefecture, Japan
🇯🇵
University of Miyazaki Faculty of Medicine, Miyazaki-city, Miyazaki-prefecture, Japan

and more 1 locations

Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

Phase 1

Completed

Conditions: Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Prostate Carcinoma Metastatic in the Bone
Stage IV Prostate Cancer AJCC v7

Interventions: Drug: Enzalutamide
Drug: Ribociclib
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Procedure: Biospecimen Collection
Procedure: Biopsy
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging

First Posted Date: 2015-09-21

Last Posted Date: 2024-05-13

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 46

Registration Number: NCT02555189

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

and more 1 locations

Niclosamide and Enzalutamide in Treating Patients With Castration-Resistant, Metastatic Prostate Cancer

Phase 1

Completed

Conditions: Castration Levels of Testosterone
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Adenocarcinoma

Interventions: Drug: Enzalutamide
Other: Laboratory Biomarker Analysis
Drug: Niclosamide
Other: Pharmacological Study

First Posted Date: 2015-08-25

Last Posted Date: 2018-04-18

Lead Sponsor: University of Washington

Target Recruit Count: 5

Registration Number: NCT02532114

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Advanced Hepatocellular Carcinoma

Interventions: Drug: Enzalutamide
Drug: Placebo

First Posted Date: 2015-08-19

Last Posted Date: 2024-12-06

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 165

Registration Number: NCT02528643

Locations: 🇨🇦
Site CA15003, Montreal, Canada
🇨🇦
Site CA15002, Montreal, Quebec, Canada
🇭🇰
Site HK85204, Shatin, Hong Kong

and more 35 locations

A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC

Phase 2

Conditions: Adenocarcinoma of the Prostate

Interventions: Drug: AZD5363
Drug: Enzalutamide

First Posted Date: 2015-08-17

Last Posted Date: 2018-08-08

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 136

Registration Number: NCT02525068

Locations: 🇬🇧
Royal Marsden Hospital, Sutton, Surrey, United Kingdom

Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer

Phase 1

Active, not recruiting

Conditions: Recurrent Prostate Carcinoma
Metastatic Prostate Carcinoma
Castration-Resistant Prostate Carcinoma
Stage IV Prostate Cancer AJCC v7

Interventions: Drug: Cabazitaxel
Drug: Enzalutamide
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Prednisone

First Posted Date: 2015-08-13

Last Posted Date: 2024-02-14

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 37

Registration Number: NCT02522715

Locations: 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
🇺🇸
Portland VA Medical Center, Portland, Oregon, United States

Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer

Phase 2

Terminated

Conditions: Prostatic Neoplasms
Pelvic Nodal

Interventions: Drug: Enzalutamide
Drug: Leuprolide
Radiation: Intensity-Modulated Radiation Therapy

First Posted Date: 2015-07-27

Last Posted Date: 2021-10-12

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 11

Registration Number: NCT02508636

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

Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone Metastasis

Phase 2

Completed

Conditions: Prostate Carcinoma Metastatic to the Bone

Interventions: Drug: Enzalutamide
Radiation: Radium ra 223 dichloride

First Posted Date: 2015-07-24

Last Posted Date: 2019-03-19

Lead Sponsor: Carolina Research Professionals, LLC

Target Recruit Count: 40

Registration Number: NCT02507570

Locations: 🇺🇸
Urology of Virginia, PLLC, Virginia Beach, Virginia, United States
🇺🇸
Associated Medical Professionals, Syracuse, New York, United States
🇺🇸
Chesapeake Urology Research Associates, Towson, Maryland, United States

and more 1 locations