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NCT01486784 · ClinicalTrials.gov registry record · Phase 1
A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01486784: Clinical Trial Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01486784 is a Phase 1 study that was terminated before completion, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01486784, a Phase 1 study, was terminated before completion, sponsored by Abramson Cancer Center at Penn Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This was initially a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL, however, the phase II portion was never initiated. This study initially targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or who are newly diagnosed and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy), and then targeted subjects 18 years of age and older with MDS and ALL.
Primary Outcome
Safety of birinapant will be measured as the number of adverse events per dosing level occurring with greater than 5% frequency in the total evaluable subject population. Adverse events are any untoward medical occurrences experienced by research study participants. These events are documented and assessed for severity and relation to the study drug by the treating investigator, using the Common Terminology for Criteria for Adverse Events for severity, and information on known side effects of th
Interventions
- DRUG Birinapant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
Why NCT01486784 stopped before completion
NCT01486784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Birinapant is the first listed.
NCT01486784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01486784 about?
NCT01486784 is a clinical study titled "A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia". This was initially a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL, however, the phase II portion was never initiated. This study initially targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or re...
What is the current status of trial NCT01486784?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2011-11. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01486784?
The interventions under investigation include: Birinapant (DRUG).
Who is sponsoring clinical trial NCT01486784?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01486784's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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