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 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: -

Clinical Trials

Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)

Phase 2

Active, not recruiting

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Enzalutamide
Drug: Talazoparib

First Posted Date: 2020-04-03

Last Posted Date: 2024-08-26

Lead Sponsor: MedSIR

Target Recruit Count: 54

Registration Number: NCT04332744

Locations: 🇪🇸
Hospital Universitario Virgen de la Victoria, Málaga, Spain
🇪🇸
Instituto Valenciano de Oncología (IVO), Valencia, Spain
🇪🇸
Institut Català d'Oncologia Badalona, Badalona, Spain

and more 5 locations

a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Completed

Conditions: Neuropathy
Prostate Cancer
Epilepsy
Encephalopathy

Interventions: Drug: Enzalutamide

First Posted Date: 2020-03-02

Last Posted Date: 2023-04-13

Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Target Recruit Count: 500000

Registration Number: NCT04290611

Locations: 🇫🇷
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière, Paris, France

Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Atezolizumab
Drug: Abiraterone
Drug: Prednisone
Drug: GnRH analog
Radiation: Stereotactic Body Radiotherapy (SBRT)
Drug: Enzalutamide
Other: Follow up

First Posted Date: 2020-02-10

Last Posted Date: 2024-02-09

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT04262154

Locations: 🇺🇸
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities), Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States

and more 5 locations

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

Phase 1

Recruiting

Conditions: Prostate Cancer

Interventions: Drug: AMG 509
Drug: Abiraterone
Drug: Enzalutamide

First Posted Date: 2020-01-09

Last Posted Date: 2024-12-18

Lead Sponsor: Amgen

Target Recruit Count: 461

Registration Number: NCT04221542

Locations: 🇺🇸
Sanford Oncology Clinic and Pharmacy, Sioux Falls, South Dakota, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
Providence Saint Jude Medical Center, Fullerton, California, United States

and more 49 locations

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Enzalutamide
Drug: Abiraterone
Drug: Opaganib

First Posted Date: 2019-12-20

Last Posted Date: 2024-06-25

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 67

Registration Number: NCT04207255

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
Emory University, Atlanta, Georgia, United States

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Phase 3

Active, not recruiting

Conditions: Metastatic Hormone-Sensitive Prostate Cancer

Interventions: Biological: Pembrolizumab
Drug: Enzalutamide
Drug: Androgen Deprivation Therapy (ADT)
Other: Placebo

First Posted Date: 2019-12-09

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1251

Registration Number: NCT04191096

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0241), Los Angeles, California, United States
🇲🇽
Grupo Medico Camino SC ( Site 2613), Mexico City, Mexico
🇩🇪
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210), Muenchen, Bayern, Germany

and more 210 locations

Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)

Phase 1

Completed

Conditions: Metastatic Castration Resistant Prostate Cancer

Interventions: Drug: Rucaparib
Drug: Abiraterone
Drug: Enzalutamide

First Posted Date: 2019-11-27

Last Posted Date: 2023-06-29

Lead Sponsor: pharmaand GmbH

Target Recruit Count: 8

Registration Number: NCT04179396

Locations: 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸
Urology Associates, P.C., Nashville, Tennessee, United States
🇺🇸
Piedmont Cancer Institute, P.C., Atlanta, Georgia, United States

A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer

Phase 1

Terminated

Conditions: Metastatic Castration-resistant Prostate Cancer
Metastatic Prostate Cancer

Interventions: Drug: Tazemetostat
Drug: Abiraterone/prednisone
Drug: Enzalutamide

First Posted Date: 2019-11-27

Last Posted Date: 2024-12-09

Lead Sponsor: Epizyme, Inc.

Target Recruit Count: 102

Registration Number: NCT04179864

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Genesis Healthcare Partners, San Diego, California, United States

and more 21 locations

Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

Phase 2

Terminated

Conditions: Prostatic Cancer, Castration-Resistant

Interventions: Drug: Darolutamide (Nubeqa, BAY1841788)
Drug: Enzalutamide

First Posted Date: 2019-11-08

Last Posted Date: 2023-08-04

Lead Sponsor: Bayer

Target Recruit Count: 30

Registration Number: NCT04157088

Locations: 🇺🇸
Oregon Health and Science University, Portland, Maine, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
MidLantic Urology - Bala Cynwyd, Bala-Cynwyd, Pennsylvania, United States

and more 4 locations

Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Phase 1

Conditions: mCRPC

Interventions: Drug: ZEN003694
Drug: Enzalutamide

First Posted Date: 2019-10-30

Last Posted Date: 2024-04-17

Lead Sponsor: Zenith Epigenetics

Target Recruit Count: 40

Registration Number: NCT04145375

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States
🇺🇸
University of California San Francisco Medical Center, San Francisco, California, United States

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