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Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS
NCT03502668 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG ASTX727 LD
- DRUG ASTX727 SD
Study Locations (20)
Florida
- Mayo Clinic Florida — Jacksonville
- BRCR Medical Center Inc. — Plantation
- Moffitt Cancer Center Site#507 — Tampa
Tennessee
- Sarah Cannon Research Institute — Nashville
- Vanderbilt University Medical Center - Hematology-Oncology — Nashville
Texas
- The University of Texas MD Anderson Cancer Center — Houston
- Texas Oncology - Tyler — Tyler
Other
- ZNA - Campus Middelheim — Antwerp
- Az St-Jan Brugge-Oostende A.V. — Bruges
Alabama
- The University of Alabama at Birmingham — Birmingham
Colorado
- University of Colorado, Anschutz Cancer Pavilion — Aurora
Connecticut
- Yale Cancer Center — New Haven
Illinois
- The University of Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-07-27 |
| Est. Completion | 2026-01-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03502668
The ClinicalTrials.gov registry entry for NCT03502668 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions — of which ASTX727 LD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03502668 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Tennessee, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03502668 about?
NCT03502668 is a clinical study titled "Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS". 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 ...
What is the current status of trial NCT03502668?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2018-07-27. Estimated completion is 2026-01-13.
What conditions does trial NCT03502668 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03502668?
The interventions under investigation include: ASTX727 LD (DRUG), ASTX727 SD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03502668?
This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03502668 being conducted?
This trial has 20 study locations across Alabama, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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