Enzalutamide

Generic Name
Enzalutamide
Brand Names
Xtandi, Enzalutamide Viatris
Drug Type
Small Molecule
Chemical Formula
C21H16F4N4O2S
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 achieve...

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
-

Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-08-13
Last Posted Date
2020-10-22
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
37
Registration Number
NCT02215096
Locations
🇬🇧

GSK Investigational Site, Sutton, United Kingdom

Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer

First Posted Date
2014-08-04
Last Posted Date
2022-01-06
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
24
Registration Number
NCT02207504
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2014-07-30
Last Posted Date
2023-05-31
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
96
Registration Number
NCT02203695
Locations
🇺🇸

Sibley Memorial Hospital, Washington, District of Columbia, United States

🇺🇸

Karmanos Cancer Center, Detroit, Michigan, United States

🇺🇸

Suburban Hospital, Bethesda, Maryland, United States

and more 6 locations

BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)

First Posted Date
2014-07-30
Last Posted Date
2023-09-11
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
120
Registration Number
NCT02204072
Locations
🇪🇸

Hospital Duran i Reynals, L'Hospitalet de Llobregat, Spain

🇪🇸

Hospital Ramón y Cajal, Madrid, Spain

🇬🇧

The Clatterbridge Cancer Centre, Bebington, Wirral, United Kingdom

and more 24 locations

Radium Ra 223 With Enzalutamide Compared to Enzalutamide Alone in Men With Metastatic Castration Refractory Prostate Cancer

First Posted Date
2014-07-24
Last Posted Date
2020-10-30
Lead Sponsor
University of Utah
Target Recruit Count
49
Registration Number
NCT02199197
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Phase III Radium 223 mCRPC-PEACE III

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2014-07-18
Last Posted Date
2024-04-05
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
446
Registration Number
NCT02194842
Locations
🇮🇹

Ospedale B.Ramazzini, Carpi, Italy

🇨🇦

Hamilton And District Urology Association, Hamilton, Ontario, Canada

🇨🇦

London Regional Cancer Center, London, Ontario, Canada

and more 61 locations

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy

First Posted Date
2014-06-10
Last Posted Date
2015-01-26
Lead Sponsor
Kenneth Pienta, MD
Registration Number
NCT02159690
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

A Study to Evaluate How a Drug That Alters Liver Enzymes (Rifampin) Affects the Metabolism of Enzalutamide in Men

First Posted Date
2014-05-15
Last Posted Date
2014-10-15
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
28
Registration Number
NCT02138799
Locations
🇩🇪

Parexel International GmbH, Berlin, Germany

A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men

First Posted Date
2014-05-14
Last Posted Date
2014-05-14
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
16
Registration Number
NCT02138162
Locations
🇧🇬

Comac Medical Ltd., Sofia, Bulgaria

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