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

Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer

First Posted Date
2016-05-12
Last Posted Date
2022-06-21
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
54
Registration Number
NCT02770391
Locations
🇺🇸

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

Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

First Posted Date
2016-03-29
Last Posted Date
2023-02-09
Lead Sponsor
University of Washington
Target Recruit Count
24
Registration Number
NCT02721979
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2016-03-09
Last Posted Date
2024-11-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
196
Registration Number
NCT02703623
Locations
🇺🇸

MD Anderson in Katy, Houston, Texas, United States

🇺🇸

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

🇺🇸

MD Anderson in Sugar Land, Sugar Land, Texas, United States

A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-10-19
Last Posted Date
2023-11-09
Lead Sponsor
Aragon Pharmaceuticals, Inc.
Target Recruit Count
45
Registration Number
NCT02578797

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

First Posted Date
2015-07-03
Last Posted Date
2024-12-09
Lead Sponsor
Aragon Pharmaceuticals, Inc.
Target Recruit Count
1052
Registration Number
NCT02489318

Micro RNAs to Predict Response to Androgen Deprivation Therapy

First Posted Date
2015-02-19
Last Posted Date
2024-11-25
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
42
Registration Number
NCT02366494
Locations
🇺🇸

Froedtert Hospital, Milwaukee, Wisconsin, United States

ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-08
Last Posted Date
2023-05-26
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
9
Registration Number
NCT02106507
Locations
🇺🇸

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

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2013-09-19
Last Posted Date
2024-12-20
Lead Sponsor
Aragon Pharmaceuticals, Inc.
Target Recruit Count
1207
Registration Number
NCT01946204
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