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Last Updated: December 4, 2021

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CLINICAL TRIALS PROFILE FOR DAROLUTAMIDE

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All Clinical Trials for darolutamide

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.
NCT03004534 ↗ A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide Completed Translational Research in Oncology 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 >Phase >Start Date >Summary

Clinical Trial Conditions for darolutamide

Condition Name

Condition Name for darolutamide
Intervention Trials
Prostate Cancer 9
Metastatic Prostate Cancer 4
Prostatic Neoplasms 4
Prostate Adenocarcinoma 4
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Condition MeSH

Condition MeSH for darolutamide
Intervention Trials
Prostatic Neoplasms 31
Adenocarcinoma 6
Breast Neoplasms 3
Neoplasms 3
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Clinical Trial Locations for darolutamide

Trials by Country

Trials by Country for darolutamide
Location Trials
United States 178
Japan 66
Brazil 48
China 39
Canada 38
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Trials by US State

Trials by US State for darolutamide
Location Trials
California 11
New York 9
Pennsylvania 8
Ohio 8
Massachusetts 8
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Clinical Trial Progress for darolutamide

Clinical Trial Phase

Clinical Trial Phase for darolutamide
Clinical Trial Phase Trials
Phase 3 10
Phase 2 16
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for darolutamide
Clinical Trial Phase Trials
Recruiting 21
Not yet recruiting 6
Active, not recruiting 5
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Clinical Trial Sponsors for darolutamide

Sponsor Name

Sponsor Name for darolutamide
Sponsor Trials
Bayer 18
Orion Corporation, Orion Pharma 4
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for darolutamide
Sponsor Trials
Other 40
Industry 34
NIH 3
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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Dow
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McKinsey
Express Scripts

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