Therapy Detail

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Therapy Name Enzalutamide
Synonyms
Therapy Description

Xtandi (enzalutamide) is a second-generation small molecule androgen receptor (AR) inhibitor that inhibits AR signaling, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA approved for use in patients with castration-resistant prostate cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Enzalutamide Xtandi MDV3100|ASP9785 Hormone - Anti-androgens 27 Xtandi (enzalutamide) is a second-generation small molecule androgen receptor (AR) inhibitor that inhibits AR signaling, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA approved for use in patients with castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown prostate cancer not applicable Enzalutamide FDA approved Actionable In a Phase III trial (PROSPER) that supported FDA approval, Xtandi (enzalutamide) significantly improved median metastasis-free survival (36.6 vs 14.7 months, HR=0.29, p<0.0001) compared to placebo in patients with non-metastatic castration-resistant prostate cancer (Journal of Clinical Oncology 36, no. 6_suppl (February 20 2018) 3-3; NCT020032924). detail... detail...
Unknown unknown prostate cancer not applicable Enzalutamide FDA approved Actionable Ina Phase III trial (ARCHES) that supported FDA approval, Xtandi (enzalutamide) treatment with androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death compared to ADT plus placebo (HR=0.39, P < .001; median not reached vs 19.0 months) in patients with metastatic hormone-sensitive prostate cancer (PMID: 31329516; NCT02677896). detail... 31329516
Unknown unknown prostate cancer not applicable Enzalutamide FDA approved Actionable In a Phase III trial (AFFIRM) that supported FDA approval, treatment with Xtandi (enzalutamide) resulted in improved median overall survival compared to placebo (18.4 vs 13.6 months HR=0.63, p<0.001) in patients with metastatic castration-resistant prostate cancer (PMID: 22894553; NCT00974311). detail... 22894553
APC inact mut prostate cancer decreased response Enzalutamide Clinical Study Actionable In a clinical study, metastatic castrate-resistant prostate cancer patients harboring a Wnt pathway activating alteration (CTNNB1 activating mutation, or APC or RNF43 inactivating mutation) demonstrated shorter median overall survival (23.6 mo vs 27.7 mo) and median time to PSA progression (6.5 mo vs 9.6 mo) compared to patients without Wnt pathway alterations, and APC or RNF43 inactivating mutations were independently associated with increased hazard of PSA progression (aHR 1.83; p=0.004) (PMID: 31176623). 31176623

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02199197 Phase II Enzalutamide Radium Ra 223 With Enzalutamide in Men With Metastatic Castration Refractory Prostate Cancer Completed
NCT02750358 Phase II Enzalutamide Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer Active, not recruiting
NCT02528643 Phase II Enzalutamide A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma Active, not recruiting
NCT02429193 Phase II Enzalutamide Abiraterone + Prednisone Biomarkers of Androgen Response and Resistance In Evolution During a Rising PSA (BARRIER-P) Completed
NCT02676986 Phase II Enzalutamide + Exemestane Exemestane Enzalutamide Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer (ARB) Active, not recruiting
NCT02885649 Phase 0 Enzalutamide Enzalutamide Before Surgery in Treating Patients With Kidney Cancer Active, not recruiting
NCT02379390 Phase II Prednisone Abiraterone Enzalutamide Cabazitaxel Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enz (PRIMCAB) Terminated
NCT02286921 Phase II Enzalutamide Testosterone Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance Completed
NCT02003924 Phase III Enzalutamide Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Active, not recruiting
NCT01949337 Phase III Abiraterone Prednisone Enzalutamide Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer Active, not recruiting
NCT02353715 Phase I Abiraterone Enzalutamide Sipuleucel-T Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge), Abiraterone Acetate (Zytiga) or Enzalutamide (Xtandi) Undergoing Cardiopulmonary EXercise Testing Completed
NCT02507570 Phase II Enzalutamide Radium Ra 223 dichloride Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone Metastasis Completed
NCT02138383 Phase I Enzalutamide Nab-paclitaxel Gemcitabine Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer Completed
NCT01942837 Phase II Enzalutamide Phase II Trial of Enzalutamide for Castrate-resistant Prostate Cancer With Correlative Assessment of Androgen Receptor Signaling Active, not recruiting
NCT02034552 Phase II Prednisone Radium Ra 223 dichloride Enzalutamide Abiraterone A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC) Completed
NCT02607228 Phase Ib/II Enzalutamide Exemestane + GS-5829 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer Completed
NCT03344211 Phase II Enzalutamide + Radium Ra 223 dichloride Enzalutamide Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer Recruiting
NCT03939689 Phase II Enzalutamide 131I-MIP-1095 + Enzalutamide Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (ARROW) Active, not recruiting
NCT02058706 Phase II Goserelin Bicalutamide Enzalutamide Leuprolide LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer Unknown status
NCT02099864 Phase II Enzalutamide Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy Active, not recruiting
NCT02194842 Phase III Enzalutamide Enzalutamide + Radium Ra 223 dichloride Phase III Radium 223 mCRPC-PEACE III (PEACE III) Recruiting
NCT04363164 Phase II Testosterone Enanthate Testosterone cypionate Enzalutamide Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression Active, not recruiting
NCT02278185 Phase II Goserelin Degarelix Histrelin acetate Triptorelin Leuprolide Enzalutamide Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer Active, not recruiting
NCT03016741 FDA approved Enzalutamide Abiraterone + Prednisone Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer Recruiting
NCT02319837 Phase III Leuprolide Enzalutamide Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
NCT03834519 Phase III Abiraterone + Prednisone Enzalutamide Olaparib + Pembrolizumab Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (KEYLYNK-010) Recruiting
NCT02452008 Phase II Galunisertib Enzalutamide Study of TGF-Beta Receptor Inhibitor LY2157299 and Enzalutamide in Metastatic Castration-resistant Prostate Cancer Recruiting
NCT02023463 Phase I Goserelin Enzalutamide Leuprolide Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer Active, not recruiting
NCT02090114 Phase II Testosterone Abiraterone Enzalutamide RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study) Recruiting
NCT02532114 Phase I Enzalutamide Niclosamide Niclosamide and Enzalutamide in Treating Patients With Androgen Receptor Splice Variant-Positive, Castration-Resistant, Metastatic Prostate Cancer Completed
NCT02749903 Phase II Enzalutamide Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers Active, not recruiting
NCT03834493 Phase III Enzalutamide + Pembrolizumab Enzalutamide 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) Recruiting
NCT02384382 Phase II Enzalutamide A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC) Completed
NCT03480646 Phase Ib/II Enzalutamide Abiraterone + CPI-1205 + Prednisone CPI-1205 + Enzalutamide ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer Active, not recruiting
NCT02605863 Phase II Enzalutamide Enzalutamide for Bladder Cancer Chemoprevention Terminated
NCT02929576 Phase III Paclitaxel Enzalutamide + Paclitaxel Enzalutamide Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer (ENDEAR) Withdrawn
NCT04237584 Phase III Darolutamide Darolutamide + Radium Ra 223 dichloride Enzalutamide Enzalutamide + Radium Ra 223 dichloride A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients (ESCALATE) Recruiting
NCT02203695 Phase II Enzalutamide Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy Active, not recruiting
NCT04191096 Phase III Enzalutamide + Pembrolizumab Enzalutamide Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Recruiting
NCT02057939 Phase II Enzalutamide Leuprolide Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) Completed
NCT02446405 Phase III Enzalutamide Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer Active, not recruiting
NCT02799745 Phase II Enzalutamide A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT) (ENACT) Active, not recruiting
NCT04335682 Phase II Darolutamide Enzalutamide Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide Not yet recruiting
NCT01974765 Phase II Enzalutamide Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies Active, not recruiting
NCT02642913 Phase Ib/II Enzalutamide Sorafenib Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients Active, not recruiting
NCT01977651 FDA approved Enzalutamide A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide Completed
NCT02489123 Phase I Enzalutamide Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma Active, not recruiting
NCT02491411 Phase I Enzalutamide Dexamethasone Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel Terminated
NCT02987543 Phase III Olaparib Enzalutamide Abiraterone Study of Olaparib (Lynparza) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) Active, not recruiting
NCT02204072 Phase I Enzalutamide Xentuzumab BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC) Active, not recruiting
NCT02685397 Phase II Enzalutamide Triptorelin Goserelin Leuprolide Management of Castration-Resistant Prostate Cancer With Oligometastases Recruiting
NCT02438007 Phase III Galeterone Enzalutamide A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC Terminated
NCT02555189 Phase Ib/II Ribociclib Enzalutamide Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression Recruiting
NCT02457910 Phase Ib/II Enzalutamide Enzalutamide + Taselisib Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer Active, not recruiting
NCT03016312 Phase III Atezolizumab + Enzalutamide Enzalutamide IMbassador250: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen Active, not recruiting
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Recruiting
NCT02960022 Phase II Abiraterone + Enzalutamide + Prednisone Enzalutamide A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study Recruiting
NCT02677896 Phase III Enzalutamide A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
NCT04015622 Phase II Docetaxel Enzalutamide PROTRACT (PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA) STUDY (PROTRACT) Not yet recruiting
NCT02125357 Phase II Enzalutamide Abiraterone Sequencing Abiraterone and Enzalutamide in mCRPC Completed
NCT03478904 Phase I Enzalutamide Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer Recruiting
NCT03809000 Phase II Goserelin Bicalutamide Enzalutamide Leuprolide A Trial to See What the Results Are for Radiation Therapy and Hormone Therapy vs Radiation Therapy With Enhanced Hormone Therapy With Enzalutamide for Patients With PSA Recurrence After Surgery (STEEL) Recruiting
NCT02446444 Phase III Enzalutamide Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer Active, not recruiting
NCT02441517 FDA approved Enzalutamide A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel Treatment in Patients Who Have Previously Received Enzalutamide Terminated
NCT01362374 Phase I Enzalutamide Paclitaxel Docetaxel Ipatasertib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Safety and Pharmacology Of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors Active, not recruiting
NCT02407054 Phase II Enzalutamide LY3023414 A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer Completed
NCT02300610 Phase I Cisplatin + Gemcitabine Enzalutamide Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer Completed
NCT04381832 Phase Ib/II AB928 + Enzalutamide + GLS-010 AB928 + Docetaxel + GLS-010 AB680 + AB928 + GLS-010 AB680 + AB928 Enzalutamide Docetaxel AB928 + GLS-010 Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer (ARC-6) Recruiting
NCT01927627 Phase II Enzalutamide Enzalutamide in Patients With High-risk Prostate Cancer Completed
NCT04446117 Phase III Enzalutamide Atezolizumab + Cabozantinib Abiraterone + Prednisone Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC (CONTACT-02) Recruiting
NCT02215096 Phase I Enzalutamide GSK2636771 Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer Completed
NCT04157088 Phase II Enzalutamide Darolutamide Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) (DaroAcT) Recruiting
NCT01867333 Phase II PROSTVAC-F-TRICOM Enzalutamide Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer Active, not recruiting
NCT02064582 Phase II Leuprolide Enzalutamide Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer Active, not recruiting
NCT02012296 Phase Ib/II Mifepristone Enzalutamide Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer Recruiting
NCT02268175 Phase II Enzalutamide Abiraterone Prednisone Leuprolide Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate Active, not recruiting
NCT02975934 Phase III Rucaparib Docetaxel Enzalutamide Abiraterone A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3) Recruiting
NCT02403505 Phase II Enzalutamide Abiraterone Prednisone Degarelix Discovery Stage Clinical Study About Oncology Drugs and Single Nucleotide Polymorphisms Active, not recruiting
NCT02500901 Phase I Niraparib Enzalutamide Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) Terminated
NCT02028988 Phase II Enzalutamide Enzalutamide + External Beam Rt For Prostate Active, not recruiting
NCT02256111 Phase II Enzalutamide EXTEND Exercise Trial Completed
NCT02254785 Phase II Abiraterone Enzalutamide Cabazitaxel Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer Unknown status


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