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Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes

NCT03906695 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-20

No results posted yet for this study

Summary

To investigate the tolerability and safety of ASTX727 in Japanese subjects with lower-risk MDS.

Conditions

  • Lower-risk Myelodysplastic

Interventions

DRUG

ASTX727

oral decitabine 5mg + cedazuridine

DRUG

ASTX727

oral decitabine 5mg + cedazuridine

DRUG

ASTX727

oral decitabine 10mg + cedazuridine

DRUG

ASTX727

oral decitabine 20mg + cedazuridine

DRUG

ASTX727

oral decitabine 10mg + cedazuridine

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nobuhito Sanada · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2026-01-31
Completion
2026-01-31

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 NCT03906695 on ClinicalTrials.gov