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NCT03502668 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Myelodysplastic Syndromes, sponsored by Taiho Oncology.

Completed
Registry status
Phase 1
Development phase
160
Enrollment target
20
Study locations

NCT03502668 is a Phase 1 study of Myelodysplastic Syndromes that has completed, run by Taiho Oncology. The registered enrollment target is 160 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT03502668, a Phase 1 study of Myelodysplastic Syndromes, has completed, sponsored by Taiho Oncology.

COMPLETED
Registry status
Phase 1
Development phase
160 participants
Enrollment target
20
Study locations

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

Myelodysplastic Syndromes

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

FieldValue
Enrollment Target 160 participants
Start Date 2018-07-27
Est. Completion 2026-01-13
Phase Phase 1

Sponsor

Taiho Oncology

52 total trials

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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, categorized as Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (44% lower). The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.

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.

NCT03502668 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Tennessee, Texas.

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.

What interventions are being tested in trial NCT03502668?

The interventions under investigation include: ASTX727 LD (DRUG), ASTX727 SD (DRUG).

Who is sponsoring clinical trial NCT03502668?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.