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NCT04638309 · ClinicalTrials.gov registry record · Phase 1
APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)
A Phase 1 study, sponsored by Aprea Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT04638309: Clinical Trial Phase 1 study, sponsored by Aprea Therapeutics.
NCT04638309 is a Phase 1 study that was terminated before completion, run by Aprea Therapeutics. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04638309, a Phase 1 study, was terminated before completion, sponsored by Aprea Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Phase 1 study evaluating the safety and efficacy of APR-548 in combination with Azacitidine for the treatment of TP53-Mutant Myelodysplastic Syndromes.
Primary Outcome
Occurrence of frequency of treatment emergent adverse events by reviewing safety data including AEs, vital signs, laboratory data, ECG, ophthalmologic assessment findings, and other physical exam findings.
Interventions
- DRUG APR-548 + Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2022-04-25 |
| Phase | Phase 1 |
Why NCT04638309 stopped before completion
NCT04638309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which APR-548 + Azacitidine is the first listed.
NCT04638309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04638309 about?
NCT04638309 is a clinical study titled "APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)". Phase 1 study evaluating the safety and efficacy of APR-548 in combination with Azacitidine for the treatment of TP53-Mutant Myelodysplastic Syndromes.
What is the current status of trial NCT04638309?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-09-20. Estimated completion is 2022-04-25.
What interventions are being tested in trial NCT04638309?
The interventions under investigation include: APR-548 + Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04638309?
This trial is sponsored by Aprea Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04638309's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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