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NCT04214860 · ClinicalTrials.gov registry record · Phase 1
APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies
A Phase 1 study, sponsored by Aprea Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT04214860: Completed Phase 1 study, sponsored by Aprea Therapeutics.
NCT04214860 is a Phase 1 study that has completed, run by Aprea Therapeutics. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04214860, a Phase 1 study, has completed, sponsored by Aprea Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.
Primary Outcome
1\. Dose-limiting toxicities (DLTs), classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG APR-246
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 1 |
What the finished NCT04214860 record still lists
NCT04214860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04214860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04214860 about?
NCT04214860 is a clinical study titled "APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies". This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.
What is the current status of trial NCT04214860?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2019-12-13. Estimated completion is 2022-01-14.
What interventions are being tested in trial NCT04214860?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), APR-246 (DRUG).
Who is sponsoring clinical trial NCT04214860?
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 NCT04214860's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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