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DRUG:

cedazuridine/azacitidine (ASTX030)

i
Other names: ASTX030
Associations
Trials
Company:
Otsuka
Drug class:
DNMT inhibitor, Cytidine deaminase inhibitor
Associations
Trials
2ms
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML (clinicaltrials.gov)
P2/3, N=317, Active, not recruiting, Taiho Oncology, Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
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cedazuridine/azacitidine (ASTX030)
3ms
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome (clinicaltrials.gov)
P1, N=40, Recruiting, Otsuka Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Nov 2024 --> Apr 2025
Trial completion date • Trial primary completion date
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cedazuridine/azacitidine (ASTX030)
over3years
The development and clinical use of oral hypomethylating agents in acute myeloid leukemia and myelodysplastic syndromes: dawn of the total oral therapy era. (PubMed, Expert Rev Anticancer Ther)
Following the approval of the cedazuridine/decitabine combination, ASTX727, as well as development of an oral formulation of azacitidine, CC-486, in the USA in 2020, these agents could gradually replace their injectable counterparts...However, their FDA-approved indications at this point are narrow and efficacy needs to be shown in clinical trials before considering use beyond the approved indications. Areas of special interest include; identification of predictive biomarkers for clinical benefit, post-transplant maintenance therapy, and potential combination therapies with other oral agents such as venetoclax, IDH and FLT3 inhibitors.
Clinical • Journal
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FLT3 (Fms-related tyrosine kinase 3)
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Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine) • Onureg (azacitidine oral) • cedazuridine/azacitidine (ASTX030)