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Clinical trials for Darolutamide

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

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    32 result(s) found for: Darolutamide. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-000823-38 Sponsor Protocol Number: CABADARO Start Date*: 2020-05-08
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: Study on the pharmacokinetic interaction between cabazitaxel and darolutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.
    Medical condition: metastatic castration-resistant prostate cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003618-15 Sponsor Protocol Number: 20321 Start Date*: 2020-06-25
    Sponsor Name:Bayer Consumer Care AG
    Full Title: An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies
    Medical condition: Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Trial now transitioned) PL (Trial now transitioned) SE (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) LT (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) PT (Completed) DE (Trial now transitioned) LV (Trial now transitioned) BG (Trial now transitioned) AT (Completed) EE (Completed) SK (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003792-41 Sponsor Protocol Number: DAROTAXEL Start Date*: 2023-05-26
    Sponsor Name:Erasmus MC
    Full Title: A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer.
    Medical condition: metastatic castration-resistant prostate cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (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: 2020-003093-48 Sponsor Protocol Number: 21140 Start Date*: 2021-04-29
    Sponsor Name:Bayer Consumer Care AG
    Full Title: A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prost...
    Medical condition: Metastatic hormone-sensitive prostate cancer (mHSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: LT (Trial now transitioned) LV (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002590-38 Sponsor Protocol Number: 17777 Start Date*: 2016-12-14
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind, placebo-controlled Phase III study of darolutamide (ODM-201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastati...
    Medical condition: Metastatic hormone-sensitive prostate cancer (mHSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) BE (Completed) ES (Completed) FI (Completed) DE (Completed) CZ (Completed) NL (Completed) PL (Completed) FR (Completed) BG (Completed) IT (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: 2013-003820-36 Sponsor Protocol Number: BAY1841788/17712 Start Date*: 2014-07-25
    Sponsor Name:Bayer AG
    Full Title: A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF DAROLUTAMIDE (DCM-201) IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
    Medical condition: High-risk, non-metastatic castration-resistant prostate cancer (MedDRA: hormonerefractory prostate cancer)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066489 Progression of prostate cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) HU (Completed) FI (Completed) LV (Completed) CZ (Completed) AT (Completed) GB (Completed) SK (Completed) DE (Completed) PT (Completed) IT (Completed) BE (Completed) BG (Completed) FR (Completed) PL (Completed) RO (Completed) LT (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004952-13 Sponsor Protocol Number: DART Start Date*: 2020-12-14
    Sponsor Name:University Hospital Ghent
    Full Title: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART)
    Medical condition: - Prostate cancer patients with a biochemical recurrence following primary therapy - Hormone-sensitive - Up to 5 metastases on PSMA PET-CT
    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: BE (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2021-006289-19 Sponsor Protocol Number: D9720C00003 Start Date*: 2023-01-17
    Sponsor Name:ASTRAZENECA AB
    Full Title: A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patie...
    Medical condition: Metastatic Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004818-34 Sponsor Protocol Number: CTRIAL-IE-19-32 Start Date*: 2021-04-23
    Sponsor Name:Cancer Trials Ireland
    Full Title: DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamid...
    Medical condition: Clinically localised prostate cancer defined as very high risk, or with very high risk features.
    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: IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004334-17 Sponsor Protocol Number: EORTC-1532-GUCG Start Date*: 2017-09-21
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: A phase 2 Randomized Open-Label Study of Oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in Men with Hormone Naive Prostate Cancer
    Medical condition: Hormone Naive 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: BE (Trial now transitioned) AT (Completed) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003542-21 Sponsor Protocol Number: ALADDIN Start Date*: 2022-02-28
    Sponsor Name:ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie
    Full Title: Evaluation of dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases
    Medical condition: Prostate cancer with pelvic lymph nodes metastases.
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002431-53 Sponsor Protocol Number: IB2021-03 Start Date*: 2022-09-23
    Sponsor Name:Institut Bergonié
    Full Title: A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER
    Medical condition: Prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036910 Prostate cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003663-26 Sponsor Protocol Number: UC-GTG-2006 Start Date*: 2021-11-19
    Sponsor Name:UNICANCER
    Full Title: A double-blind randomised phase III trial evaluating the efficacy of ADT +/- darolutamide in de novo metastatic prostate cancer patients with vulnerable functional ability and not elected for docet...
    Medical condition: Adenocarcinoma of the prostate
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003141-28 Sponsor Protocol Number: CCR4500 Start Date*: 2017-04-04
    Sponsor Name:The Institute of Cancer Research
    Full Title: ACE: Proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC)
    Medical condition: Metastatic castration resistant prostate cancer
    Disease:
    Population Age: Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003996-23 Sponsor Protocol Number: SAKK08/16 Start Date*: 2017-08-29
    Sponsor Name:SAKK
    Full Title: ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with one novel hormonal agent first line and nonprogressive disease after sec...
    Medical condition: Metastatic castration resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007453 Carcinoma of the prostate metastatic LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Prematurely Ended) ES (Ongoing) FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000348-77 Sponsor Protocol Number: XL184-315 Start Date*: 2020-07-22
    Sponsor Name:Exelixis, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant ...
    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: HU (Completed) GB (GB - no longer in EU/EEA) PT (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) AT (Completed) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000082-41 Sponsor Protocol Number: 2021-0486 Start Date*: 2022-03-31
    Sponsor Name:Fundación para la Investigación en Urología
    Full Title: Impact of pitavastatin use in prostate cancer patients treated with new generation androgen therapy: multicenter clinical trial
    Medical condition: We propose a multicenter, prospective, randomized, single-blind clinical trial, without conflict of interest, to determine the clinical benefit of statins (Pitavastatin 2 mg) in prostate cancer pa...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000290-24 Sponsor Protocol Number: I3Y-MC-JPCY Start Date*: 2020-08-17
    Sponsor Name:Eli Lilly and Company
    Full Title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated with a Novel Hormonal Agent and Taxane-based Chemotherapy
    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) 10076506 Castration-resistant prostate cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed)
    Trial results: View results
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