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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 is a Phase 2 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01993641
The ClinicalTrials.gov registry entry for NCT01993641 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT01993641 reports 0 study locations.
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.
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