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
-

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2024-01-05
Last Posted Date
2024-04-09
Lead Sponsor
Celcuity Inc
Target Recruit Count
54
Registration Number
NCT06190899
Locations
🇪🇸

Institut Catala d'Oncologia, Barcelona, Spain

🇪🇸

Hospital Clinic Barcelona, Barcelona, Spain

🇪🇸

Hospital General Universitario Gregorio Maranon, Madrid, Spain

and more 10 locations

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

First Posted Date
2023-12-15
Last Posted Date
2024-12-18
Lead Sponsor
Mamta Parikh
Target Recruit Count
75
Registration Number
NCT06173362
Locations
🇺🇸

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

First Posted Date
2023-12-13
Last Posted Date
2024-12-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
37
Registration Number
NCT06169124
Locations
🇺🇸

Cancer Hematology Centers - Flint, Flint, Michigan, United States

🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Helen F Graham Cancer Center, Newark, Delaware, United States

and more 64 locations

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

First Posted Date
2023-11-07
Last Posted Date
2024-11-27
Lead Sponsor
AstraZeneca
Target Recruit Count
1800
Registration Number
NCT06120491
Locations
🇬🇧

Research Site, Truro, United Kingdom

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

First Posted Date
2023-08-21
Last Posted Date
2024-05-30
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
10
Registration Number
NCT05999968
Locations
🇪🇸

Hospital General Universitario Gregorio Marañon, Madrid, Madrid, Comunidad De, Spain

🇺🇸

Highlands Oncology Group, Springdale, Arkansas, United States

🇩🇪

Studienpraxis Urologie, Nürtingen, Baden-Württemberg, Germany

and more 10 locations

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

First Posted Date
2023-07-10
Last Posted Date
2024-12-13
Lead Sponsor
AstraZeneca
Target Recruit Count
120
Registration Number
NCT05938270
Locations
🇬🇧

Research Site, Newcastle upon Tyne, United Kingdom

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2023-04-19
Last Posted Date
2024-12-10
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
200
Registration Number
NCT05818683
Locations
🇺🇸

Washington University School Of Medicine, Saint Louis, Missouri, United States

🇺🇸

Sidney Kimmel Cancer Center - Jefferson Health, Philadelphia, Pennsylvania, United States

🇺🇸

Florida Cancer Specialists, Sarasota, Florida, United States

and more 5 locations

Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

First Posted Date
2023-03-16
Last Posted Date
2023-09-14
Lead Sponsor
GenesisCare USA
Registration Number
NCT05771896

Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

First Posted Date
2023-03-09
Last Posted Date
2024-06-27
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
245
Registration Number
NCT05762536
Locations
🇳🇱

Erasmus MC Cancer Institute, Rotterdam, Netherlands

Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2023-01-23
Last Posted Date
2024-06-21
Lead Sponsor
National Cancer Center Hospital East
Target Recruit Count
56
Registration Number
NCT05694819
Locations
🇯🇵

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

🇯🇵

National Hospital Organization Kyushu Medical Center, Fukuoka, Japan

🇯🇵

Tohoku University Hospital, Sendai, Miyagi, Japan

and more 9 locations
© Copyright 2024. All Rights Reserved by MedPath