^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    Cytidine deaminase inhibitor

    Related drugs:
    9d
    Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=35, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting | Trial completion date: Dec 2026 --> Jul 2027 | Trial primary completion date: Jan 2026 --> Sep 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    decitabine • Inqovi (decitabine/cedazuridine)
    9d
    NCI-2021-06095: ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P1/2, N=42, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2026 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation • FLT3 mutation
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • Inqovi (decitabine/cedazuridine)
    22d
    ASCENT1: Research Study Investigating How Well NDec Works in People With Sickle Cell Disease (clinicaltrials.gov)
    P2, N=96, Completed, Novo Nordisk A/S | Trial primary completion date: Dec 2024 --> Jul 2025
    Trial primary completion date
    |
    hydroxyurea • decitabine/ tetrahydrouridine (EPI01)
    29d
    Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma (clinicaltrials.gov)
    P2, N=9, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    BAP1 (BRCA1 Associated Protein 1)
    |
    Inqovi (decitabine/cedazuridine)
    1m
    ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas (clinicaltrials.gov)
    P1, N=18, Recruiting, Massachusetts General Hospital | Trial completion date: May 2025 --> Aug 2028 | Trial primary completion date: May 2024 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Inqovi (decitabine/cedazuridine)
    1m
    Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm (clinicaltrials.gov)
    P2, N=132, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    1m
    Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy) (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Feb 2026 --> May 2026
    Trial initiation date
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine) • Rezlidhia (olutasidenib)
    1m
    Testing the Combination of Targeted Radiotherapy With Anti-Cancer Drugs, Venetoclax and ASTX-727, to Improve Outcomes for Adults With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=53, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine) • Actimab-A (lintuzumab-Ac225)
    1m
    ASCERTAIN-V: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1/2, N=101, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    1m
    Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov)
    P1/2, N=8, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Oct 2025 --> Aug 2026
    Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    2ms
    Venetoclax/FluBu2 RIC transplant followed by all-oral venetoclax/decitabine maintenance for poor risk MDS/AML. (PubMed, Blood Adv)
    To improve the tolerability of post-transplant maintenance and outcomes despite poor risk disease genetics, we conducted a phase 1 study of venetoclax/FluBu2 RIC transplantation with tacrolimus/methotrexate GVHD prophylaxis followed by all-oral venetoclax/decitabine-cedazuridine (ven/dec-c) maintenance in poor-risk MDS/AML patients (N=30). PROs assessed in first 6-months of maintenance were stable except for emotional function, which improved (P=0.008). Trial is registered at clinicaltrials.gov/NCT03613532.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • methotrexate • Inqovi (decitabine/cedazuridine)
    2ms
    Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1/2, N=3, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Drug company withdrew support.
    Trial termination
    |
    Inqovi (decitabine/cedazuridine) • eltanexor (KPT-8602)