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NCT01828346 · ClinicalTrials.gov registry record · Phase 1
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
A Phase 1 study, sponsored by TetraLogic Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01828346: Completed Phase 1 study, sponsored by TetraLogic Pharmaceuticals.
NCT01828346 is a Phase 1 study that has completed, run by TetraLogic Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01828346, a Phase 1 study, has completed, sponsored by TetraLogic Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.
Interventions
- DRUG 5-Azacitidine
- DRUG Birinapant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
What the finished NCT01828346 record still lists
NCT01828346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which 5-Azacitidine is the first listed.
NCT01828346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01828346 about?
NCT01828346 is a clinical study titled "Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy". This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate path...
What is the current status of trial NCT01828346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2013-06. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01828346?
The interventions under investigation include: 5-Azacitidine (DRUG), Birinapant (DRUG).
Who is sponsoring clinical trial NCT01828346?
This trial is sponsored by TetraLogic Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01828346's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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