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Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS

NCT03502668 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-03

No results posted yet for this study

Summary

Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.

Conditions

Interventions

DRUG

ASTX727 LD

oral decitabine (LD) + cedazuridine (E7727)

DRUG

ASTX727 SD

oral decitabine (SD) + cedazuridine (E7727)

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2026-01-13
Completion
2026-01-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT03502668 on ClinicalTrials.gov