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 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
- -
Effect of a Reduced Dose Enzalutamide in Frail (m)CRPC Patients on Cognitive Side Effects
- First Posted Date
- 2019-04-25
- Last Posted Date
- 2024-06-12
- Lead Sponsor
- Radboud University Medical Center
- Target Recruit Count
- 57
- Registration Number
- NCT03927391
- Locations
- 🇳🇱
Franciscus Gasthuis en Vlietland hospital, Rotterdam, Netherlands
🇳🇱CWZ, Nijmegen, Netherlands
🇳🇱Radboudumc, Nijmegen, Netherlands
Pan Tumor Rollover Study
- Conditions
- Interventions
- Drug: NivolumabDrug: LeucovorinDrug: Nivolumab + RelatlimabDrug: RegorafinibDrug: CapecitabineDrug: PemetrexedDrug: EnzalutamideDrug: SunitinibDrug: PembrolizumabDrug: RelatlimabDrug: TemozolomideDrug: RucaparibDrug: IpilimumabDrug: DaratumumabDrug: FluorouracilDrug: CabozantinibDrug: TrametinibDrug: BevacizumabDrug: Oxaliplatin
- First Posted Date
- 2019-04-02
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1500
- Registration Number
- NCT03899155
- Locations
- 🇧🇷
Local Institution - 0260, Belo Horizonte, Minas Gerais, Brazil
🇨🇳Harbin Medical University - Cancer Hospital, Harbin, Heilongjiang, China
🇨🇳Local Institution - 0172, Changsha, Hunan, China
Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).
- Conditions
- Interventions
- First Posted Date
- 2019-04-01
- Last Posted Date
- 2021-12-29
- Lead Sponsor
- Bayer
- Target Recruit Count
- 346
- Registration Number
- NCT03896984
- Locations
- 🇺🇸
US Flatiron prostate cancer database, Whippany, New Jersey, United States
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAnatomic Stage IV Breast Cancer AJCC v8AnemiaAnn Arbor Stage III Hodgkin LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCastration-Resistant Prostate Carcinoma
- Interventions
- Drug: AbemaciclibDrug: AbirateroneDrug: AfatinibBiological: BevacizumabDrug: BicalutamideProcedure: Biospecimen CollectionDrug: BortezomibDrug: CabazitaxelDrug: CabozantinibDrug: CapecitabineDrug: CarboplatinDrug: CelecoxibDrug: CobimetinibDrug: CopanlisibDrug: DabrafenibDrug: DacomitinibDrug: DarolutamideDrug: DasatinibDrug: DoxorubicinBiological: DurvalumabDrug: EnasidenibDrug: EntrectinibDrug: EnzalutamideDrug: ErlotinibDrug: EverolimusDrug: FluorouracilDrug: IdelalisibDrug: ImatinibBiological: IpilimumabDrug: LenvatinibDrug: LeucovorinDrug: LorlatinibDrug: LosartanDrug: Nab-paclitaxelDrug: NeratinibBiological: NivolumabDrug: OlaparibDrug: OxaliplatinDrug: PalbociclibDrug: PanobinostatBiological: PembrolizumabBiological: PertuzumabDrug: PonatinibOther: Quality-of-Life AssessmentDrug: RegorafenibDrug: RuxolitinibDrug: SirolimusDrug: SorafenibDrug: SunitinibDrug: TrametinibBiological: Trastuzumab EmtansineDrug: TretinoinDrug: VemurafenibDrug: VenetoclaxDrug: VismodegibDrug: Vorinostat
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT03878524
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-03-04
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 11
- Registration Number
- NCT03860987
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Conditions
- Interventions
- First Posted Date
- 2019-02-22
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Hinova Pharmaceuticals USA, Inc.
- Target Recruit Count
- 104
- Registration Number
- NCT03850795
- Locations
- 🇵🇱
NZOZ Centrum Urologiczne Sp zoo, Mysłowice, Slaskie, Poland
🇫🇷Hopital d'Instruction des Armées de Begin, Saint-Mandé, France
🇳🇱Antonius Ziekenhuis, Sneek, Friesland, Netherlands
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
- Conditions
- Interventions
- First Posted Date
- 2019-02-08
- Last Posted Date
- 2024-02-02
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 793
- Registration Number
- NCT03834519
- Locations
- 🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0081), Los Angeles, California, United States
🇨🇦Princess Margaret Cancer Centre ( Site 0107), Toronto, Ontario, Canada
🇺🇸Beth Israel Deaconess Medical Ctr. ( Site 0093), Boston, Massachusetts, United States
Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
- Conditions
- Interventions
- First Posted Date
- 2019-02-08
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1244
- Registration Number
- NCT03834493
- Locations
- 🇺🇸
St. Joseph Heritage Healthcare ( Site 0069), Fullerton, California, United States
🇺🇸Georgia Cancer Center at Augusta University ( Site 0026), Augusta, Georgia, United States
🇺🇸Gabrail Cancer Center-Research ( Site 0096), Canton, Ohio, United States
Combination of Entinostat and Enzalutamide in Advanced Prostate Cancer
- First Posted Date
- 2019-02-04
- Last Posted Date
- 2021-08-02
- Lead Sponsor
- George Washington University
- Target Recruit Count
- 6
- Registration Number
- NCT03829930
- Locations
- 🇺🇸
George Washington University - Medical Faculty Associates, Washington, District of Columbia, United States
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
- Conditions
- Interventions
- First Posted Date
- 2019-01-18
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- RTOG Foundation, Inc.
- Target Recruit Count
- 188
- Registration Number
- NCT03809000
- Locations
- 🇺🇸
USC Medical Center - Los Angeles County, Los Angeles, California, United States
🇺🇸University of Southern California, Los Angeles, California, United States
🇺🇸Sutter Roseville Medical Center, Roseville, California, United States
Drug Development Updates
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