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

PET/CT and WB MRI for Staging and Response in CRPC Patients Receiving Enzalutamide

Phase 2

Completed

Conditions: Prostate Cancer Metastatic

Interventions: Drug: Enzalutamide
Device: 18-FDG PET/CT
Device: Whole body MRI
Device: Bone scan

First Posted Date: 2016-06-28

Last Posted Date: 2022-04-14

Lead Sponsor: The European Uro-Oncology Group

Target Recruit Count: 66

Registration Number: NCT02814968

Locations: 🇳🇱
Leiden University Medical Center, Leiden, Netherlands

Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide

Phase 2

Completed

Conditions: Prostate Cancer Metastatic

Interventions: Drug: Enzalutamide
Procedure: 11C or 18F-Choline PET/CT
Procedure: Whole body MRI
Procedure: Bone scan

First Posted Date: 2016-06-28

Last Posted Date: 2022-04-14

Lead Sponsor: The European Uro-Oncology Group

Target Recruit Count: 66

Registration Number: NCT02815033

Locations: 🇳🇱
Leiden University Medical Center, Leiden, Netherlands

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Enzalutamide
Other: Active Surveillance

First Posted Date: 2016-06-15

Last Posted Date: 2024-12-06

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 227

Registration Number: NCT02799745

Locations: 🇺🇸
Site US10038, Chicago, Illinois, United States
🇺🇸
Site US10056, Dallas, Texas, United States
🇨🇦
Site CA15003, Toronto, Ontario, Canada

and more 51 locations

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Biological: Denosumab
Drug: Enzalutamide
Drug: Abiraterone
Drug: Prednisone

First Posted Date: 2016-05-02

Last Posted Date: 2019-11-08

Lead Sponsor: University of Hawaii

Target Recruit Count: 1

Registration Number: NCT02758132

Locations: 🇺🇸
University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

Phase 2

Conditions: Salivary Cancer

Interventions: Drug: enzalutamide

First Posted Date: 2016-04-25

Last Posted Date: 2021-10-26

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 46

Registration Number: NCT02749903

Locations: 🇺🇸
Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States
🇺🇸
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
🇺🇸
Dayton Physicians LLC-Wayne, Greenville, Ohio, United States

and more 284 locations

Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Early Stage
Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Enzalutamide
Behavioral: assessment

First Posted Date: 2016-04-25

Last Posted Date: 2024-06-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 50

Registration Number: NCT02750358

Locations: 🇺🇸
Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Coney Island Hospital, Brooklyn, New York, United States

and more 9 locations

A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

Phase 1

Completed

Conditions: Advanced Solid Malignancies
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Carcinoma (CRC)
Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC)

Interventions: Drug: AZD4635
Drug: Durvalumab
Drug: Enzalutamide
Drug: Abiraterone Acetate
Drug: Docetaxel
Drug: Oleclumab

First Posted Date: 2016-04-18

Last Posted Date: 2023-05-26

Lead Sponsor: AstraZeneca

Target Recruit Count: 313

Registration Number: NCT02740985

Locations: 🇺🇸
Research Site, Nashville, Tennessee, United States

A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 1

Completed

Conditions: Metastatic Castration-Resistant Prostate Cancer

Interventions: Drug: ZEN003694
Drug: Enzalutamide

First Posted Date: 2016-03-17

Last Posted Date: 2021-11-30

Lead Sponsor: Zenith Epigenetics

Target Recruit Count: 75

Registration Number: NCT02711956

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Weill Cornell Medicine - New York Presbyterian, New York, New York, United States
🇺🇸
University of California San Francisco Medical Center, San Francisco, California, United States

and more 4 locations

Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer

Phase 2

Completed

Conditions: Invasive Breast Carcinoma
Stage I Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage II Breast Cancer AJCC v6 and v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage III Breast Cancer AJCC v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIB Breast Cancer AJCC v7

Interventions: Procedure: Axillary Lymph Node Dissection
Drug: Enzalutamide
Other: Laboratory Biomarker Analysis
Procedure: Lymph Node Biopsy
Drug: Paclitaxel
Procedure: Therapeutic Conventional Surgery

First Posted Date: 2016-02-24

Last Posted Date: 2023-11-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT02689427

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

Management of Castration-Resistant Prostate Cancer with Oligometastases

Phase 2

Active, not recruiting

Conditions: Castration-resistant Prostate Cancer Patients with Oligometastases

Interventions: Drug: Leuprolide Acetate
Drug: Goserelin Acetate
Drug: Triptorelin
Drug: Enzalutamide
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2016-02-18

Last Posted Date: 2024-12-04

Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Target Recruit Count: 102

Registration Number: NCT02685397

Locations: 🇨🇦
BC CANCER Vancouver, Vancouver, British Columbia, Canada
🇨🇦
CancerCare Manitoba, Winnipeg, Manitoba, Canada
🇨🇦
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada

and more 8 locations

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