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    DRUG:

    Nubeqa (darolutamide)

    i
    Other names: ODM-201, BAY-1841788 , ODM 201, BAY 1841788
    Company:
    Bayer, Orion Corp
    Drug class:
    Androgen receptor inhibitor
    Related drugs:
    9d
    QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P1 trial
    |
    Nubeqa (darolutamide) • itraconazole • MHB088C • rifampicin
    9d
    PARIS-BIO: Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore (clinicaltrials.gov)
    P2, N=100, Recruiting, Region Stockholm
    New P2 trial
    |
    Nubeqa (darolutamide)
    13d
    AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (clinicaltrials.gov)
    P3, N=670, Recruiting, AstraZeneca
    New P3 trial
    |
    FOLH1 positive
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • cabazitaxel • apalutamide • Xofigo (radium Ra-223 dichloride) • AiRuiEn (rezvilutamide) • FPI-2265 • prednisolone
    14d
    Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Sir Mortimer B. Davis - Jewish General Hospital | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> Nov 2030 | Trial primary completion date: Nov 2027 --> Nov 2030
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Nubeqa (darolutamide)
    14d
    EvoPAR-PR01: Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (clinicaltrials.gov)
    P3, N=1889, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2028 --> Sep 2027
    Enrollment closed • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • saruparib (AZD5305)
    15d
    23146: How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany (clinicaltrials.gov)
    P=N/A, N=500, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open • HEOR • Real-world evidence
    |
    Nubeqa (darolutamide)
    28d
    CHINANEO: A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. (clinicaltrials.gov)
    P2, N=250, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Nubeqa (darolutamide) • goserelin acetate
    1m
    ASCERTAIN: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (clinicaltrials.gov)
    P1, N=120, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Nubeqa (darolutamide) • saruparib (AZD5305)
    1m
    A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P1, N=60, Recruiting, Daiichi Sankyo | N=13 --> 60
    Enrollment change • Trial initiation date
    |
    KLK3 (Kallikrein-related peptidase 3)
    |
    Nubeqa (darolutamide) • Ezharmia (valemetostat)
    2ms
    PICASSO: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction (clinicaltrials.gov)
    P2, N=4, Completed, St Vincent's Hospital, Sydney | Recruiting --> Completed | N=22 --> 4
    Trial completion • Enrollment change
    |
    dasatinib • Nubeqa (darolutamide)
    2ms
    Prospective Single-Arm Study of Prostate Cytoreductive Surgery in Combination with ADT + Darotarotide + Docetaxel for the Treatment of New Oligometastatic Hormone-Sensitive Prostate Cancer (Phase II Clinical Trial) (ChiCTR2600121389)
    P2, N=30, The First Affiliated Hospital of Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University
    New P2 trial
    |
    docetaxel • Nubeqa (darolutamide)
    2ms
    A real-world retrospective study evaluating the ADT combined with docetaxel and darolutamide triple therapy regimen for metastatic prostate cancer(YHCG-006) (ChiCTR2600118253)
    P4, N=111, The First Affiliated Hospital of Ningbo University; The First Affiliated Hospital of Ningbo University
    New P4 trial • Real-world evidence
    |
    docetaxel • Nubeqa (darolutamide)