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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT03502668

Public ClinicalTrials.gov record NCT03502668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 9:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects With Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03502668
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Taiho Oncology, Inc.
Industry
Enrollment
160 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 27, 2018 (Actual)
Primary completion
Jan 13, 2026 (Actual)
Completion
Jan 13, 2026 (Actual)
Last update posted
Apr 3, 2026

2018 – 2026

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
The University of Alabama at Birmingham Birmingham Alabama 35233 —
University of Colorado, Anschutz Cancer Pavilion Aurora Colorado 80045 —
Yale Cancer Center New Haven Connecticut 06510 —
Mayo Clinic Florida Jacksonville Florida 32224 —
BRCR Medical Center Inc. Plantation Florida 33324 —
Moffitt Cancer Center Site#507 Tampa Florida 33612 —
The University of Chicago Chicago Illinois 60637 —
Indiana University Health Hospital - Simon Cancer Center Indianapolis Indiana 46202 —
University of Kansas Clinical Research Center Westwood Kansas 66205 —
The Center for Cancer and Blood Disorders (RCCA MD LLC - Maryland Division) Bethesda Maryland 20817 —
Mayo Clinic Rochester Minnesota 55905 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Roswell Park Comprehensive Cancer Center Buffalo New York 14263 —
Oregon Health and Science University Knight Cancer Institute Portland Oregon 97239 —
Sarah Cannon Research Institute Nashville Tennessee 37203 —
Vanderbilt University Medical Center - Hematology-Oncology Nashville Tennessee 37232 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030 —
Texas Oncology - Tyler Tyler Texas 75702 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03502668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 3, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03502668 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →