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NCT04160052 · ClinicalTrials.gov registry record · Phase 1
Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT04160052: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04160052 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. 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
NCT04160052, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of venetoclax when given together with azacitidine in treating patients with high-risk myelodysplastic syndrome that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Primary Outcome
The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle dose-limiting toxicity.
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2026-02-03 |
| Phase | Phase 1 |
Why NCT04160052 stopped before completion
NCT04160052 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 2 interventions - of which Venetoclax is the first listed.
NCT04160052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04160052 about?
NCT04160052 is a clinical study titled "Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome". This phase I/II trial studies the side effects and best dose of venetoclax when given together with azacitidine in treating patients with high-risk myelodysplastic syndrome that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as venetoclax an...
What is the current status of trial NCT04160052?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2019-10-01. Estimated completion is 2026-02-03.
What interventions are being tested in trial NCT04160052?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04160052?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04160052'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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