Apalutamide

Generic Name
Apalutamide
Brand Names
Erleada
Drug Type
Small Molecule
Chemical Formula
C21H15F4N5O2S
CAS Number
956104-40-8
Unique Ingredient Identifier
4T36H88UA7
Background

Apalutamide is a potent androgen receptor (AR) antagonist that selectively binds to the ligand-binding domain of AR and blocks AR nuclear translocation or binding to androgen response elements . It has been used in trials studying the treatment of Prostate Cancer, Hepatic Impairment, Prostatic Neoplasms, Castration-Resistant Prostate Cancer, and Prostatic Ne...

Indication

Apalutamide is indicated for the treatment of patients with metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.

Associated Conditions
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Non-Metastatic Castration-Resistant Prostate Cancer
Associated Therapies
Androgen Deprivation Therapy

A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-01-14
Last Posted Date
2020-08-10
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
12
Registration Number
NCT03802682
Locations
🇧🇪

Clinical Pharmacology Unit, Merksem, Belgium

Conventional ADT w/ or w/Out Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

First Posted Date
2018-12-19
Last Posted Date
2024-06-24
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
12
Registration Number
NCT03777982
Locations
🇺🇸

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

🇺🇸

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center, Milford, Massachusetts, United States

🇺🇸

Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital, South Weymouth, Massachusetts, United States

and more 2 locations

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

First Posted Date
2018-12-06
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
2517
Registration Number
NCT03767244
Locations
🇺🇸

UC Davis Medical Center, Sacramento, California, United States

🇺🇸

AdventHealth Medical Group Urology of Denver, Denver, Colorado, United States

🇺🇸

Colorado Clinical Research, Lakewood, Colorado, United States

and more 199 locations

A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-05-14
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
19
Registration Number
NCT03523442
Locations
🇨🇳

Beijing Cancer Hospital of Peking University, Beijing, China

🇨🇳

Jiangsu Cancer Hospital, NanJing, China

🇨🇳

Peking University Third Hospital, Beijing, China

and more 1 locations

An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2018-05-14
Last Posted Date
2023-12-13
Lead Sponsor
Aragon Pharmaceuticals, Inc.
Registration Number
NCT03523338
Locations
🇧🇷

Ynova Pesquisa Clinica, Florianopolis, Brazil

🇧🇷

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil

🇧🇷

Fundacao Antonio Prudente - A.C. Camargo Cancer Center, Sao Paulo, Brazil

and more 9 locations

Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer

First Posted Date
2018-04-19
Last Posted Date
2024-02-23
Lead Sponsor
University of California, San Francisco
Target Recruit Count
26
Registration Number
NCT03503344
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

First Posted Date
2018-02-19
Last Posted Date
2024-11-28
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
102
Registration Number
NCT03436654
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Northwestern University, Evanston, Illinois, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 8 locations

Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

First Posted Date
2018-01-26
Last Posted Date
2024-07-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
50
Registration Number
NCT03412396
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

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