Enzalutamide
- Generic Name
- Enzalutamide
- Brand Names
- Xtandi, Enzalutamide Viatris
- Drug Type
- Small Molecule
- Chemical Formula
- C21H16F4N4O2S
- 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
- -
A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients
- Conditions
- Interventions
- First Posted Date
- 2012-07-26
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 60
- Registration Number
- NCT01650194
- Locations
- 🇺🇸
Site US2492 MD Anderson Cancer Ctr, Houston, Texas, United States
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2012-05-11
- Last Posted Date
- 2019-05-08
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 101
- Registration Number
- NCT01597193
- Locations
- 🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸Tennessee Oncology, PLLC., Nashville, Tennessee, United States
🇺🇸Karmanos Cancer Institute, Detroit, Michigan, United States
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2012-03-07
- Last Posted Date
- 2018-10-23
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 52
- Registration Number
- NCT01547299
A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
- Conditions
- Interventions
- First Posted Date
- 2012-02-16
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 52
- Registration Number
- NCT01534052
- Locations
- 🇲🇩
Site MD37301, Chisinau, Moldova, Republic of
🇿🇦Site ZA2701, George, South Africa
🇿🇦Site ZA2702, Port Elizabeth, South Africa
Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2011-05-30
- Last Posted Date
- 2022-01-12
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 122
- Registration Number
- NCT01362374
- Locations
- 🇫🇷
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, France
🇺🇸Florida Cancer Specialists - Sarasota, Sarasota, Florida, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy
- First Posted Date
- 2011-02-23
- Last Posted Date
- 2018-10-02
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 67
- Registration Number
- NCT01302041
- Locations
- 🇧🇪
Site BE1002, Kortrijk, Belgium
🇨🇿Site CZ3006, Olomouc, Czechia
🇩🇪Site DE5005, Aachen, Germany
A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
- First Posted Date
- 2011-02-03
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 375
- Registration Number
- NCT01288911
- Locations
- 🇷🇴
Site RO3042, Bucharest, RO, Romania
🇷🇴Site RO3039, Bucharest, RO, Romania
🇷🇴Site RO3035, Bucharest, Romania
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
- First Posted Date
- 2010-10-01
- Last Posted Date
- 2020-03-17
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 1717
- Registration Number
- NCT01212991
- Locations
- 🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
🇺🇸North County Oncology Medical Clinic, Inc, Oceanside, California, United States
🇺🇸Levine Cancer Institute - Main, Charlotte, North Carolina, United States
Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide
- Conditions
- Interventions
- First Posted Date
- 2010-03-23
- Last Posted Date
- 2018-10-23
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 60
- Registration Number
- NCT01091103
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2009-09-10
- Last Posted Date
- 2018-12-11
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 1199
- Registration Number
- NCT00974311
- Locations
- 🇺🇸
LAC & USC Medical Center, Los Angeles, California, United States
🇺🇸Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
🇺🇸Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.