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    DRUG:

    Inqovi (decitabine/cedazuridine)

    i
    Other names: ASTX727, ASTX 727, oral C-DEC, DEC-C
    Company:
    Otsuka
    Drug class:
    DNMT inhibitor, Cytidine deaminase inhibitor
    Related drugs:
    5d
    DECISIVO: Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, PETHEMA Foundation
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    cytarabine • Tibsovo (ivosidenib) • Inqovi (decitabine/cedazuridine) • hydroxyurea
    13d
    NIBIT-ML-1: A randomized, run-in, phase II study of nivolumab combined with ipilimumab and oral decitabine/cedazuridine (ASTX727) or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 (2024-518891-29-00)
    P1/2, N=148, Recruiting, Fondazione NIBIT Onlus | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • BRAF mutation • ALK translocation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Inqovi (decitabine/cedazuridine)
    22d
    ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 (clinicaltrials.gov)
    P1/2, N=31, Not yet recruiting, University of Wisconsin, Madison
    New P1/2 trial
    |
    Inqovi (decitabine/cedazuridine) • Zynyz (retifanlimab-dlwr)
    29d
    ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jan 2027
    Trial completion date
    |
    Inqovi (decitabine/cedazuridine) • Beleodaq (belinostat) • guadecitabine (SGI-110)
    1m
    Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=126, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • PML (Promyelocytic Leukemia)
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    1m
    Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=93, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Venclexta (venetoclax) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    1m
    ASTX660-03: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Taiho Oncology, Inc. | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2026 --> Mar 2026
    Phase classification • Trial completion date
    |
    Inqovi (decitabine/cedazuridine) • tolinapant (ASTX660)
    1m
    DECISIVO: A study to evaluate the safety and efficacy of oral decitabine plus ivosidenib in newly diagnosed adult patients with acute myeloid leukemia older than 60 years and/or inelegible for standard induction chemotherapy (2025-523238-17-00)
    P1/2, N=50, Not yet recruiting, Fundacion PETHEMA
    New P1/2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    decitabine • Tibsovo (ivosidenib) • Inqovi (decitabine/cedazuridine)
    2ms
    Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms (clinicaltrials.gov)
    P2, N=27, Recruiting, University of Washington | Not yet recruiting --> Recruiting
    Enrollment open
    |
    azacitidine • Inqovi (decitabine/cedazuridine) • Vonjo (pacritinib)
    2ms
    A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=47, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2026 --> Oct 2026
    Trial initiation date
    |
    CD4 (CD4 Molecule)
    |
    Inqovi (decitabine/cedazuridine) • Neupogen (filgrastim)
    2ms
    A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST) (clinicaltrials.gov)
    P2, N=25, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    SUZ12 (SUZ12 Polycomb Repressive Complex 2 Subunit)
    |
    EZH2 mutation
    |
    Inqovi (decitabine/cedazuridine)
    2ms
    ASTX727-03: Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS (clinicaltrials.gov)
    P1/2, N=160, Completed, Taiho Oncology, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    Inqovi (decitabine/cedazuridine)