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A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome

NCT04608110 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Myelodysplastic Syndrome (MDS)

Interventions

DRUG

ASTX030 (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.

DRUG

ASTX030 (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.

DRUG

ASTX030 (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.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Taiho Pharmaceutical Co., Ltd. · Taiho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04608110 on ClinicalTrials.gov