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NCT03238248 · ClinicalTrials.gov registry record · Phase 2
Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT03238248: Completed Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT03238248 is a Phase 2 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03238248, a Phase 2 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
Primary Outcome
Overall survival time is defined as time from day 1 in cycle 1 to death for any reason. Patiens alive at last follow up were censored. Overall survival time will be summarized using the method of Kaplan and Meier.
Interventions
- DRUG Azacitidine Subcutaneous Injection or Intravenous Infusion
- DRUG Pevonedistat Infusion
- PROCEDURE Bone Marrow Biopsy & Aspirate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2023-11-27 |
| Phase | Phase 2 |
What the finished NCT03238248 record still lists
NCT03238248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine Subcutaneous Injection or Intravenous Infusion is the first listed.
NCT03238248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03238248 about?
NCT03238248 is a clinical study titled "Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors". This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
What is the current status of trial NCT03238248?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2017-08-07. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT03238248?
The interventions under investigation include: Azacitidine Subcutaneous Injection or Intravenous Infusion (DRUG), Pevonedistat Infusion (DRUG), Bone Marrow Biopsy & Aspirate (PROCEDURE).
Who is sponsoring clinical trial NCT03238248?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03238248's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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