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
Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer
- First Posted Date
- 2017-03-23
- Last Posted Date
- 2019-09-27
- Lead Sponsor
- Institut Paoli-Calmettes
- Target Recruit Count
- 206
- Registration Number
- NCT03088124
- Locations
- 🇫🇷
Chu Pontchaillou, Rennes, France
🇫🇷Chu Saint Etienne, Saint Etienne, France
🇫🇷Hia Sainte Anne, Toulon, France
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-01-04
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- Alliance Foundation Trials, LLC.
- Target Recruit Count
- 504
- Registration Number
- NCT03009981
- Locations
- 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Atlantic Health System/Morristown Medical Center, Morristown, New Jersey, United States
🇺🇸The Toledo Clinic, Toledo, Ohio, United States
A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
- Conditions
- Interventions
- First Posted Date
- 2016-10-05
- Last Posted Date
- 2020-07-20
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 34
- Registration Number
- NCT02924766
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
- Conditions
- Interventions
- First Posted Date
- 2016-09-23
- Last Posted Date
- 2024-06-27
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 16
- Registration Number
- NCT02913196
- Locations
- 🇺🇸
Weill Cornell Medical College, New York, New York, United States
🇺🇸GU Research Network/Urology Cancer Center, Omaha, Nebraska, United States
A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-09-20
- Last Posted Date
- 2016-11-22
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT02906605
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
- Conditions
- Interventions
- First Posted Date
- 2016-09-16
- Last Posted Date
- 2024-07-24
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 118
- Registration Number
- NCT02903368
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸University of California, San Diego Moores Cancer Center, La Jolla, California, United States
Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels
- Conditions
- Interventions
- First Posted Date
- 2016-08-15
- Last Posted Date
- 2021-07-07
- Lead Sponsor
- Latin American Cooperative Oncology Group
- Target Recruit Count
- 128
- Registration Number
- NCT02867020
- Locations
- 🇧🇷
Beneficiencia Portuguesa de São Paulo/Hospital São José, São Paulo, Brazil
🇧🇷Hospital Erasto Gaertner, Curitiba, Paraná, Brazil
🇧🇷IBCC, São Paulo, Brazil
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy
- Conditions
- Interventions
- First Posted Date
- 2016-07-29
- Last Posted Date
- 2022-01-13
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 22
- Registration Number
- NCT02849990
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer
- Locations
- 🇺🇸
UTHealth Memorial Hermann Cancer Center, Houston, Texas, United States
Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-06-03
- Last Posted Date
- 2022-09-15
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- Target Recruit Count
- 64
- Registration Number
- NCT02789878
- Locations
- 🇧🇷
Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, SP, Brazil
Drug Development Updates
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