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    DRUG:

    fosciclopirox (CPX-POM)

    i
    Other names: CPX-POM, ciclopirox prodrug
    Associations

    News

    Trials
    Company:
    BioNovus, University of Kansas Medical Center
    Drug class:
    γ-secretase inhibitor
    Related drugs:
    Associations

    News

    Trials
    10ms
    Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=9, Completed, CicloMed LLC | Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    fosciclopirox (CPX-POM)
    10ms
    CPX-POM-003: Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=18, Terminated, CicloMed LLC | Phase classification: P1b/2a --> P1/2 | N=28 --> 18 | Recruiting --> Terminated; Discontinued
    Phase classification • Enrollment change • Trial termination • Combination therapy
    |
    cytarabine • fosciclopirox (CPX-POM)
    10ms
    Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors (clinicaltrials.gov)
    P2, N=12, Completed, CicloMed LLC | Active, not recruiting --> Completed
    Trial completion
    |
    fosciclopirox (CPX-POM)
    over3years
    Fosciclopirox suppresses growth of high-grade urothelial cancer by targeting the γ-secretase complex. (PubMed, Cell Death Dis)
    Additionally, there was a reduction in Presenilin 1 and Hes-1 expression in the bladder tissues of CPX-POM treated animals. Following the completion of the first-in-human Phase 1 trial (NCT03348514), the pharmacologic activity of fosciclopirox is currently being characterized in a Phase 1 expansion cohort study of muscle-invasive bladder cancer patients scheduled for cystectomy (NCT04608045) as well as a Phase 2 trial of newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors (NCT04525131).
    Journal
    |
    HES1 (Hes Family BHLH Transcription Factor 1)
    |
    fosciclopirox (CPX-POM)
    5years
    Window of opportunity trial to characterize the safety, pharmacokinetics, and pharmacodynamics of fosciclopirox (CPX-POM) in cisplatin-ineligible muscle invasive bladder cancer patients. (ASCO-GU 2020)
    Clinical trial information: NCT03348514. Research Funding: CicloMed LLC.
    Clinical • PK/PD data
    |
    NOTCH1 (Notch 1) • CD8 (cluster of differentiation 8) • PCNA (Proliferating cell nuclear antigen)
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    cisplatin • fosciclopirox (CPX-POM)
    5years
    Safety, dose tolerance, pharmacokinetics, and pharmacodynamics of fosciclopirox (CPX-POM) in patients with advanced solid tumors. (ASCO-GU 2020)
    IV CPX-POM was well tolerated with treatment-related AEs primarily CNS-related. At MTD, systemic and urinary CPX exposures exceeding in vitro IC50 values by several-fold. The 900 mg/m2 dose is currently being evaluated in an expansion cohort study in cisplatin-ineligible muscle invasive bladder cancer patients scheduled for cystectomy.
    Clinical • PK/PD data
    |
    NOTCH1 (Notch 1) • IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    cisplatin • fosciclopirox (CPX-POM)
    5years
    Safety, dose tolerance, pharmacokinetics, and pharmacodynamics of fosciclopirox (CPX-POM) in patients with advanced solid tumors. (ASCO-GU 2020)
    IV CPX-POM was well tolerated with treatment-related AEs primarily CNS-related. At MTD, systemic and urinary CPX exposures exceeding in vitro IC50 values by several-fold. The 900 mg/m2 dose is currently being evaluated in an expansion cohort study in cisplatin-ineligible muscle invasive bladder cancer patients scheduled for cystectomy.
    Clinical • PK/PD data
    |
    NOTCH1 (Notch 1) • IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    cisplatin • fosciclopirox (CPX-POM)
    5years
    Window of opportunity trial to characterize the safety, pharmacokinetics, and pharmacodynamics of fosciclopirox (CPX-POM) in cisplatin-ineligible muscle invasive bladder cancer patients. (ASCO-GU 2020)
    Clinical trial information: NCT03348514. Research Funding: CicloMed LLC.
    Clinical • PK/PD data
    |
    NOTCH1 (Notch 1) • CD8 (cluster of differentiation 8) • PCNA (Proliferating cell nuclear antigen)
    |
    cisplatin • fosciclopirox (CPX-POM)