NCT04608110

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
DRUG	ASTX030	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

Timeline

• Start date: 2020-10-30
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2020-10-29
• Last updated: 2025-12-03

Locations

10 sites across 1 country: Japan