OncoMatch/Clinical Trials/NCT04608110
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
Is NCT04608110 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ASTX030 for myelodysplastic syndrome (mds).
Treatment: ASTX030 — The purpose of this study is to identify the doses of the oral azacitidine formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage LOW, INTERMEDIATE-1 (International Prognostic Scoring System (IPSS))
Low-risk patients who fall under the risk category of low or intermediate-1 (Int-1) based on the International Prognostic Scoring System (IPSS) can be enrolled only if they are unlikely to respond to any other treatment or if they are currently being treated with azacytidine (AZA) injection
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Patients who have received chemotherapy ... for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)
Cannot have received: hormone therapy
Patients who have received ... hormone therapy ... for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)
Cannot have received: antibody therapy
Patients who have received ... antibody therapy ... for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)
Cannot have received: radiotherapy
Patients who have received ... radiotherapy ... for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)
Cannot have received: exploratory anti-cancer treatments
Patients who have received ... other exploratory anti-cancer treatments for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)
Cannot have received: investigational medicinal product
Patients who have used any other IMP or any privately imported medicine within 4 weeks prior to the first administration of IMP
Cannot have received: hematopoietic stem cell transplantation
Patients who previously underwent or plan on undergoing hematopoietic stem cell transplantation
Lab requirements
Kidney function
Serum creatinine ≤ 1.5 × ULN OR creatinine clearance or GFR ≥ 50 mL/min
Liver function
Total bilirubin ≤ 2.0 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Hepatic function: Total bilirubin ≤ 2.0 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance or GFR ≥ 50 mL/min. Respiratory function: SpO2 ≥ 90%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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