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OncoMatch/Clinical Trials/NCT04608110

A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome

Is NCT04608110 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies ASTX030 (AZA + CED) for myelodysplastic syndrome (mds).

Phase 1RecruitingTaiho Pharmaceutical Co., Ltd.NCT04608110Data as of Sep 2026Location: Japan

Treatment: ASTX030 (AZA + CED)\[Tolerability Assessment Part\] The purpose is to identify the doses of the oral azacitidine(AZA) formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2. \[Expansion Assessment Part\] The purpose is to compare the total AUC for AZA after administration of ASTX030 with that after administration of AZA injection at 75 mg/m2.

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Extracted eligibility criteria

Treatments studied

Other

ASTX030 (AZA + CED)

Cancer type

Myelodysplastic Syndrome

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≥ 20

Prior therapy

Cannot have received: DNA methylation inhibitor (decitabine, azacitidine)

Patients who have received prior treatment with DNA methylation inhibitors, such as decitabine or AZA

Cannot have received: hematopoietic stem cell transplantation with evidence of GVHD

Patients who previously underwent hematopoietic stem cell transplantation and have evidence of graft-versus-host disease (GVHD)

Lab requirements

Kidney function

creatinine clearance or glomerular filtration rate ≥ 50 ml/min

Liver function

total bilirubin ≤ 2.0 × uln; ast ≤ 2.5 × uln; alt ≤ 2.5 × uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04608110 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior DNA methylation inhibitor, hematopoietic stem cell transplantation with evidence of GVHD disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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