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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01828346
The ClinicalTrials.gov registry entry for NCT01828346 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TetraLogic Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 5-Azacitidine is the first listed.
NCT01828346 reports 0 study locations.
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.
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