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
-

A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

First Posted Date
2013-11-07
Last Posted Date
2024-12-06
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
424
Registration Number
NCT01977651
Locations
🇦🇺

Site AU61011, Sydney, New South Wales, Australia

🇺🇸

Site US10039, Syracuse, New York, United States

🇺🇸

Site US10008, Dallas, Texas, United States

and more 73 locations

Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies

First Posted Date
2013-11-03
Last Posted Date
2023-04-28
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
59
Registration Number
NCT01974765
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

and more 3 locations

Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

First Posted Date
2013-09-24
Last Posted Date
2023-09-28
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
1311
Registration Number
NCT01949337
Locations
🇺🇸

Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States

🇺🇸

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

🇺🇸

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

and more 533 locations

Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide

First Posted Date
2013-09-19
Last Posted Date
2019-12-06
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
69
Registration Number
NCT01946165
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer

First Posted Date
2013-09-16
Last Posted Date
2022-10-24
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
67
Registration Number
NCT01942837
Locations
🇺🇸

South Shore Hospital, Weymouth, Massachusetts, United States

🇺🇸

University of Washington Medical Center/Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 2 locations

Enzalutamide in Patients With High-risk Prostate Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-08-22
Last Posted Date
2019-03-20
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
42
Registration Number
NCT01927627
Locations
🇺🇸

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

First Posted Date
2013-06-28
Last Posted Date
2024-12-13
Lead Sponsor
Pfizer
Target Recruit Count
118
Registration Number
NCT01889238
Locations
🇺🇸

Rocky Mountain Cancer Center Sky Ridge, Lone Tree, Colorado, United States

🇺🇸

Texas Oncology - Memorial City, Houston, Texas, United States

🇺🇸

Florida Cancer Specialist South Division, Fort Myers, Florida, United States

and more 67 locations

Tivozanib + Enzalutamide in Adv Prostate Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2013-06-25
Last Posted Date
2024-03-13
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
5
Registration Number
NCT01885949
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-08-14
Last Posted Date
2019-01-30
Lead Sponsor
Pfizer
Target Recruit Count
396
Registration Number
NCT01664923
Locations
🇺🇸

Alliance Urology Specialists, PA, Greensboro, North Carolina, United States

🇺🇸

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

🇺🇸

UCLA Clark Urology Clinic, Los Angeles, California, United States

and more 77 locations
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