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Decitabine and cedazuridine
Decitabine inhibits DNA methyltransferase to reactivate silenced tumor suppressor genes, while cedazuridine protects decitabine from deamination, allowing oral administration.
Decitabine inhibits DNA methyltransferase to reactivate silenced tumor suppressor genes, while cedazuridine protects decitabine from deamination, allowing oral administration. Used for Myelodysplastic syndromes (MDS), Acute myeloid leukemia (AML).
At a glance
| Generic name | Decitabine and cedazuridine |
|---|---|
| Also known as | ASTX727, ASTX 727, ASTX-727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727 |
| Sponsor | Race Oncology Ltd |
| Drug class | Hypomethylating agent |
| Target | DNA methyltransferase (DNMT) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Decitabine is a hypomethylating agent that inhibits DNA methyltransferase, leading to demethylation of DNA and reactivation of epigenetically silenced genes including tumor suppressors. Cedazuridine is a cytidine deaminase inhibitor that prevents the rapid degradation of decitabine, enabling effective oral bioavailability of the combination. This allows decitabine to exert its anti-neoplastic effects in hematologic malignancies.
Approved indications
- Myelodysplastic syndromes (MDS)
- Acute myeloid leukemia (AML)
Common side effects
- Myelosuppression (anemia, thrombocytopenia, neutropenia)
- Nausea and vomiting
- Fatigue
- Diarrhea
- Constipation
- Febrile neutropenia
Key clinical trials
- Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm (PHASE2)
- A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs) (PHASE2)
- 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 (PHASE1)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- 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 (PHASE1)
- Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (PHASE2)
- Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma (PHASE1)
- Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |