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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: Completed Phase 1 study of Myelodysplastic Syndromes, sponsored by Taiho Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Phase 1: Safety
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 |
What the finished NCT03502668 record still lists
NCT03502668 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (44% lower).
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 names 20 study sites across 15 states, led by 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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Where NCT03502668's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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