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    DRUG:

    apalutamide

    i
    Other names: ARN 509, JNJ56021927, JNJ-927, JNJ-56021927, ARN-509, ARN509, JNJ 56021927, JNJ927, JNJ 927
    Company:
    Generic mfg.
    Drug class:
    Androgen receptor antagonist
    Related drugs:
    18h
    DynaMO: Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=196, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Mar 2026 --> Mar 2028 | Trial primary completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    Yervoy (ipilimumab) • carboplatin • abiraterone acetate • prednisone • cabazitaxel • apalutamide
    1d
    OBSAPA: A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France (clinicaltrials.gov)
    P=N/A, N=270, Recruiting, Janssen Cilag S.A.S.
    New trial
    |
    apalutamide
    7d
    Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=26, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2025 --> Oct 2026
    Trial primary completion date
    |
    Xtandi (enzalutamide) • abiraterone acetate • apalutamide • Provenge (sipuleucel-T)
    9d
    Sustained Drug-Drug Interaction Between Cyclosporine and Apalutamide in a Patient With Metastatic Hormone-Sensitive Prostate Cancer: A Case Report and Evaluation of CYP3A4 Induction via Pregnane X Receptor Activation by Apalutamide. (PubMed, Case Rep Oncol Med)
    A 75-year-old man with mHSPC was treated with Apa and leuprorelin. Apa induced CYP3A4 via the PXR pathway, leading to a sustained DDI with CsA. Careful monitoring is necessary when Apa is coadministered with CYP3A4 substrates.
    Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    apalutamide • cyclosporine • leuprolide acetate for depot suspension
    10d
    APEX-01: ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=183, Active, not recruiting, Janssen Research & Development, LLC | N=50 --> 183
    Enrollment change • First-in-human
    |
    FOLH1 positive
    |
    abiraterone acetate • prednisone • apalutamide • JNJ-8177
    10d
    PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. (clinicaltrials.gov)
    P=N/A, N=168, Completed, First Affiliated Hospital of Wenzhou Medical University
    New trial
    |
    docetaxel • Xtandi (enzalutamide) • apalutamide
    11d
    Transcriptomic analysis to uncover the mechanism of radiosensitization of AR-positive triple-negative breast cancers with AR inhibition. (PubMed, NPJ Breast Cancer)
    Mechanistically, while stimulation with the AR-agonist R1881 is sufficient to induce nuclear translocation of AR in AR+ TNBC cells, AR inhibition with enzalutamide, apalutamide, or darolutamide blocked AR nuclear translocation. These findings suggest that AR-mediated radioresistance is at least partially due to downstream MAPK/ERK signaling. Together this work builds on the mechanistic understanding of AR-mediated radioresistance in AR+ TNBC which may expose vulnerabilities in resistance to combination treatment with AR inhibition and RT.
    Journal
    |
    AR (Androgen receptor)
    |
    AR positive
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    17d
    APEX-01: ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | N=183 --> 50 | Trial completion date: Dec 2028 --> Dec 2026 | Trial primary completion date: Jun 2027 --> Dec 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • First-in-human
    |
    FOLH1 positive
    |
    abiraterone acetate • prednisone • apalutamide • JNJ-8177
    18d
    INT22-09-01: Study to Determine Possible Effects of Apalutamide, Compared to Placebo, on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P1, N=80, Not yet recruiting, University of Wisconsin, Madison | Trial completion date: Jul 2027 --> Dec 2028 | Trial primary completion date: Jan 2027 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    EGFR expression
    |
    apalutamide
    22d
    A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=277, Recruiting, Janssen Research & Development, LLC | N=185 --> 277
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • pasritamig (JNJ-8343)
    22d
    Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Beth Israel Deaconess Medical Center | Recruiting --> Active, not recruiting | N=15 --> 9 | Trial completion date: Feb 2026 --> Sep 2026
    Enrollment closed • Enrollment change • Trial completion date
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    22d
    Double-DARE: A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics (clinicaltrials.gov)
    P=N/A, N=1400, Recruiting, Bayer
    New trial • Real-world evidence
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide