Darolutamide

Generic Name
Darolutamide
Brand Names
Nubeqa
Drug Type
Small Molecule
Chemical Formula
C19H19ClN6O2
CAS Number
1297538-32-9
Unique Ingredient Identifier
X05U0N2RCO
Background

Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists. Though prior treatment for prostate cancer has been successful for these patient...

Indication

Darolutamide is indicated for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

Associated Conditions
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Non-Metastatic Castration-Resistant Prostate Cancer
Associated Therapies
-

Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers

First Posted Date
2023-01-03
Last Posted Date
2024-12-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT05669664
Locations
🇺🇸

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States

🇺🇸

Los Angeles General Medical Center, Los Angeles, California, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 19 locations

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

First Posted Date
2022-11-16
Last Posted Date
2024-08-20
Lead Sponsor
Praful Ravi, MB BCHir, MRCP
Target Recruit Count
9
Registration Number
NCT05617885
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

First Posted Date
2022-05-10
Last Posted Date
2024-12-18
Lead Sponsor
AstraZeneca
Target Recruit Count
190
Registration Number
NCT05367440
Locations
🇬🇧

Research Site, Plymouth, United Kingdom

TT-702 in Patients With Advanced Solid Tumours.

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2022-03-09
Last Posted Date
2024-05-13
Lead Sponsor
Cancer Research UK
Target Recruit Count
188
Registration Number
NCT05272709
Locations
🇬🇧

The Christie NHS Foundation Trust, Manchester, United Kingdom

🇬🇧

Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom

🇬🇧

University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score

First Posted Date
2021-09-20
Last Posted Date
2024-11-27
Lead Sponsor
NRG Oncology
Target Recruit Count
2050
Registration Number
NCT05050084
Locations
🇺🇸

Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States

🇺🇸

Arizona Center for Cancer Care-Peoria, Peoria, Arizona, United States

🇺🇸

Arizona Center for Cancer Care - Phoenix, Phoenix, Arizona, United States

and more 532 locations

Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2021-06-14
Last Posted Date
2023-04-12
Lead Sponsor
St Vincent's Hospital, Sydney
Target Recruit Count
22
Registration Number
NCT04925648
Locations
🇦🇺

Kinghorn Cancer Centre, St. Vincent's Hospital, Sydney, New South Wales, Australia

🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

First Posted Date
2021-02-03
Last Posted Date
2023-11-13
Lead Sponsor
David VanderWeele
Target Recruit Count
6
Registration Number
NCT04737109
Locations
🇺🇸

Penn State Cancer Institute, Hershey, Pennsylvania, United States

🇺🇸

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

🇺🇸

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

First Posted Date
2020-11-23
Last Posted Date
2024-02-28
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
124
Registration Number
NCT04641078
Locations
🇧🇪

AZ St-Jan Brugge, Brugge, Belgium

🇧🇪

AZ St-Lucas Gent, Gent, Belgium

🇧🇪

Ghent University Hospital, Ghent, Belgium

and more 5 locations

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-09-22
Last Posted Date
2024-04-02
Lead Sponsor
Latin American Cooperative Oncology Group
Target Recruit Count
51
Registration Number
NCT04558866
Locations
🇧🇷

CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas), Rio De Janeiro, Brazil

🇧🇷

HMV - Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil

🇧🇷

Hospital Sírio-Libanês SP, São Paulo, Brazil

and more 3 locations

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

First Posted Date
2020-07-24
Last Posted Date
2024-12-10
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
27
Registration Number
NCT04484818
Locations
🇺🇸

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

Los Angeles County-USC Medical Center, Los Angeles, California, United States

and more 112 locations
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