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

59 participants

Start Date

Oct 30, 2020

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndrome (MDS)

Summary

\[Tolerability Assessment Part\] 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.

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 (AZA + CED)

In Cycle 1 (28 days per cycle), subcutaneous (SC) AZA will be administered on Day 1, followed by oral AZA formulations and CED tablets on Days 2-7. In Cycle 2 and onward, oral AZA formulations and CED tablets will be administered on Day 1-7.

DRUGASTX030 (AZA + CED)

In Cycle 1 (28 days per cycle), ASTX030 will be administered on Days 1-7. In Cycle 2, SC AZA will be administered on Days 1-7 according to a crossover design. From Cycle 3 onward, ASTX030 will be administered on Days 1-7.

DRUGASTX030 (AZA + CED)

In Cycle 1 (28 days per cycle), SC AZA will be administered on Days 1-7. In Cycle 2, ASTX030 will be administered on Days 1-7 according to a crossover design. From Cycle 3 onward, ASTX030 will be administered on Days 1-7.