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NCT01993641 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA
A Phase 2 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01993641: Completed Phase 2 study, sponsored by Helsinn Healthcare.
NCT01993641 is a Phase 2 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01993641, a Phase 2 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent hypomethylating agent (HMA), and to provide additional safety and efficacy data.
Primary Outcome
Clinical Improvement Rate defined as the proportion of patients with CR, Marrow CR, PR, and HI.
Interventions
- DRUG Azacitidine
- DRUG Decitabine
- DRUG pracinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT01993641 record still lists
NCT01993641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT01993641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01993641 about?
NCT01993641 is a clinical study titled "Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA". The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent hypomethylating agent (HMA), and to pro...
What is the current status of trial NCT01993641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2013-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01993641?
The interventions under investigation include: Azacitidine (DRUG), Decitabine (DRUG), pracinostat (DRUG).
Who is sponsoring clinical trial NCT01993641?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01993641's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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