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Clinical trials for Androgen receptor antagonist

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44346   clinical trials with a EudraCT protocol, of which   7374   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    20 result(s) found for: Androgen receptor antagonist. Displaying page 1 of 1.
    EudraCT Number: 2012-003981-42 Sponsor Protocol Number: 2012.2708 Start Date*: 2014-10-20
    Sponsor Name:University Medical Center Groningen [...]
    1. University Medical Center Groningen
    2. VUMC
    Full Title: Estrogen receptor and androgen receptor imaging in metastatic breast cancer patients
    Medical condition: Estrogen receptor positive metastatic breast cancer patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002284-18 Sponsor Protocol Number: UC-0140/1711 Start Date*: 2017-12-02
    Sponsor Name:UNICANCER
    Full Title: A randomized phase 2 study in patients with triple-negative, androgen receptor positive locally advanced (unresectable) or metastatic breast cancer treated with darolutamide or capecitabine
    Medical condition: Triple-negative androgen receptor positive (molecular apocrine-like HER2-negative subtype) locally advanced (unresectable) or metastatic breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Trial now transitioned) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005079-10 Sponsor Protocol Number: TOK-200-15 Start Date*: 2015-07-14
    Sponsor Name:Tokai Pharmaceuticals Inc
    Full Title: ARMOR3-SV: A Phase 3, Randomized, Open-Label, Multi-Center, Controlled Study of Galeterone Compared with Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA with Metastatic Cast...
    Medical condition: Androgen receptor (AR) splice variant-7 (ARV7), metastatic (M1) castration resistant prostate cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10007453 Carcinoma of the prostate metastatic LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) GB (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001789-39 Sponsor Protocol Number: LAVA1207-001 Start Date*: 2021-07-13
    Sponsor Name:LAVA Therapeutics N.V.
    Full Title: A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cel...
    Medical condition: Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-000722-54 Sponsor Protocol Number: MDV3100-10(C3431013) Start Date*: 2013-10-17
    Sponsor Name:Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.
    Full Title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Can...
    Medical condition: Patients With Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) FI (Completed) DE (Ongoing) SK (Completed) BE (Completed) SE (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-004711-50 Sponsor Protocol Number: 9785-MA-1001 Start Date*: 2014-11-24
    Sponsor Name:Astellas Pharma Europe Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients...
    Medical condition: Metastatic Castrate Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) IT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) SE (Prematurely Ended) ES (Prematurely Ended) GR (Completed) BE (Completed) FR (Completed) AT (Ongoing) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-002249-13 Sponsor Protocol Number: 3125001 Start Date*: 2019-02-04
    Sponsor Name:Orion Corporation Orion Pharma
    Full Title: SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BRE...
    Medical condition: METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10076506 Castration-resistant prostate cancer LLT
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004764-10 Sponsor Protocol Number: EPI-506-CS-0001 Start Date*: 2016-07-20
    Sponsor Name:Essa Pharmaceuticals Corp.
    Full Title: A Phase 1/2 Open-label Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of Oral EPI-506 in Patients with Metastatic Castration-resistant Prostate Cancer
    Medical condition: Metastatic Castration-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003291-47 Sponsor Protocol Number: RHMCAN1235 Start Date*: 2017-01-25
    Sponsor Name:University Hospital Southampton NHS Trust
    Full Title: A phase Ib/IIa clinical trial to combine the CSF1 receptor inhibitor pexidartinib with the androgen receptor antagonist enzalutamide in metastatic castration resistant prostate cancer
    Medical condition: Metastatic Castration Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004676-29 Sponsor Protocol Number: LPS14201 Start Date*: 2015-07-22
    Sponsor Name:Sanofi-aventis Groupe
    Full Title: A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)- targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated with Docetaxel and Who...
    Medical condition: prostate cancer metastatic
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Completed) BE (Completed) NL (Completed) IE (Completed) GR (Completed) FR (Completed) IS (Completed) AT (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002495-20 Sponsor Protocol Number: 000108 Start Date*: 2018-02-15
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Rece...
    Medical condition: Advanced Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071119 Hormone-dependent prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SK (Completed) CZ (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) GR (Completed) FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000099-27 Sponsor Protocol Number: HEAT01 Start Date*: 2017-04-26
    Sponsor Name:The Department of Urology
    Full Title: Toxicity of first-line abiraterone versus enzalutamide in men with metastatic castration-resistant prostate cancer: A randomized clinical trial
    Medical condition: Metastisc castration resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-004365-13 Sponsor Protocol Number: CTOR18001GZA Start Date*: 2019-02-04
    Sponsor Name:GZA vzw
    Full Title: A phase II randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-adrogen therapy...
    Medical condition: Prostate cancer patients with biochemical progression after radical prostatectomy and planned for salvage radiotherapy
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001574-28 Sponsor Protocol Number: AT13387-04 Start Date*: 2012-10-09
    Sponsor Name:Astex Pharmaceuticals Inc
    Full Title: A Phase 2 Study of Hsp90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone
    Medical condition: Castration-Resistant Prostate Cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-004381-19 Sponsor Protocol Number: NBI-74788-CAH2006 Start Date*: 2021-06-07
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by O...
    Medical condition: Classic Congenital Adrenal Hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004151-79 Sponsor Protocol Number: TRIO030 Start Date*: 2017-05-08
    Sponsor Name:Translational Research in Oncology (TRIO)
    Full Title: A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)
    Medical condition: Early Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006192 Breast cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002525-29 Sponsor Protocol Number: UC-0140/1206 Start Date*: 2013-03-08
    Sponsor Name:UNICANCER
    Full Title: A phase II trial evaluating the Activity of Abiraterone Acetate plus Prednisone in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.
    Medical condition: Molecular apocrine locally advanced or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-002534-23 Sponsor Protocol Number: 3124001 Start Date*: 2018-02-08
    Sponsor Name:Orion Corporation Orion Pharma
    Full Title: SAFETY AND PHARMACOKINETICS OF ODM-208 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
    Medical condition: Metastatic castration-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Trial now transitioned) FR (Trial now transitioned) GB (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2016-002179-91 Sponsor Protocol Number: MLE4901-101 Start Date*: 2017-01-17
    Sponsor Name:Millendo Therapeutics, Inc.
    Full Title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
    Medical condition: Polycystic Ovary Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004872 10065161 Polycystic ovarian syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004873-17 Sponsor Protocol Number: NBI-74788-CAH3003 Start Date*: 2020-10-15
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-...
    Medical condition: Classic Congenital Adrenal Hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) AT (Trial now transitioned) NL (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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