NCT03906695

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

A Multicenter, Open-label, Dose-escalation, Phase 1 Trial to Investigate the Tolerability and Safety of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Lower-risk Myelodysplastic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-15
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2019-04-08
• Last updated: 2025-03-20

Locations

1 site across 1 country: Japan