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Last Updated: April 18, 2024

CLINICAL TRIALS PROFILE FOR DAROLUTAMIDE

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All Clinical Trials for Darolutamide

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02200614 ↗	Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer	Completed	Orion Corporation, Orion Pharma	Phase 3	2014-09-12	The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
NCT02200614 ↗	Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer	Completed	Bayer	Phase 3	2014-09-12	The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
NCT02799602 ↗	ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer	Active, not recruiting	Orion Corporation, Orion Pharma	Phase 3	2016-11-30	The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
NCT02799602 ↗	ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer	Active, not recruiting	Bayer	Phase 3	2016-11-30	The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
NCT03004534 ↗	A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide	Completed	Bayer	Early Phase 1	2017-09-05	The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects. The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for Darolutamide

Condition Name

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Condition Name for Darolutamide
Intervention	Trials
Prostate Cancer	17
Metastatic Prostate Cancer	7
Prostate Adenocarcinoma	5
Prostatic Neoplasms	4
[disabled in preview]	0
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Condition MeSH

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Condition MeSH for Darolutamide
Intervention	Trials
Prostatic Neoplasms	47
Adenocarcinoma	7
Hypersensitivity	5
Carcinoma	4
[disabled in preview]	0
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Clinical Trial Locations for Darolutamide

Trials by Country

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Trials by Country for Darolutamide
Location	Trials
United States	199
Japan	79
Brazil	54
China	45
Germany	44
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Trials by US State

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Trials by US State for Darolutamide
Location	Trials
California	12
Massachusetts	11
New York	10
Pennsylvania	9
Ohio	9
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Clinical Trial Progress for Darolutamide

Clinical Trial Phase

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Clinical Trial Phase for Darolutamide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	14
Phase 2	25
[disabled in preview]	12
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Clinical Trial Status

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Clinical Trial Status for Darolutamide
Clinical Trial Phase	Trials
Recruiting	23
Not yet recruiting	21
Active, not recruiting	5
[disabled in preview]	5
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Clinical Trial Sponsors for Darolutamide

Sponsor Name

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Sponsor Name for Darolutamide
Sponsor	Trials
Bayer	29
National Cancer Institute (NCI)	4
Orion Corporation, Orion Pharma	4
[disabled in preview]	4
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Sponsor Type

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Sponsor Type for Darolutamide
Sponsor	Trials
Other	53
Industry	48
NIH	4
[disabled in preview]	1
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