RecruitingPhase 1NCT04608110

A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome

A Phase 1, Multi-center, Open-label, Uncontrolled, Dose-escalation Study to Evaluate the Pharmacokinetics of ASTX030 in Patients With Myelodysplastic Syndrome (MDS)

Sponsor

Taiho Pharmaceutical Co., Ltd.

Enrollment

40 participants

Start Date

Oct 30, 2020

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndrome (MDS)

Summary

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

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ASTX030 for people with myelodysplastic syndrome (mds). The study is currently recruiting participants at 10 locations. People eligible for this study include aged 20 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGASTX030

In Cycle 1 (28 days per cycle), single dose oral azacitidine formulations will be administered on day -3, followed by subcutaneous (SC) azacitidine on day 1, oral azacitidine formulations and cedazuridine tablets on day 2-7; in Cycle 2 and onward, oral azacitidine formulations and cedazuridine tablets will be administered on day 1-7