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NCT02091063 · ClinicalTrials.gov registry record · Phase 1
ACY-1215 for Relapsed/Refractory Lymphoid Malignancies
A Phase 1 study, sponsored by Jennifer Amengual.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02091063: Clinical Trial Phase 1 study, sponsored by Jennifer Amengual.
NCT02091063 is a Phase 1 study that was terminated before completion, run by Jennifer Amengual. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02091063, a Phase 1 study, was terminated before completion, sponsored by Jennifer Amengual.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215 for the treatment of patients with relapsed or refractory lymphoid malignancies. The target population will include patients with histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's lymphoma, with an expansion cohort of patients with mantle cell lymphoma. The phase Ib will be conducted to determine the safety and tolerability of two dosing schedules of ACY-1215 monotherapy in patients with lymphoid malignancies. Patients will be accrued simultaneously to two dose cohorts (Arm A and Arm B) of ACY-1215. Selection into each cohort will occur by alternation. All patients will take the prescribed dose of ACY-1215 orally for 28 consecutive days. Patients enrolled into Arm A will take ACY-1215 160 mg daily (QD), whereas patients enrolled into Arm B will take ACY-1215 160 mg twice daily (BID). ACY-1215 will be supplied as a liquid for oral administration (PO). Each dose will be administered at least 1 hour after ingestion of food followed by at least 4 ounces of water. Patients will be instructed not to ingest food or other oral medication for at least 2 hours after each ACY-1215 dose. Frequency in phase II will be determined based on Phase Ib results.
Primary Outcome
This is designed to establish the safety of 2 dose schedules of ACY-1215 in patients with relapsed or refractory lymphoid malignancies treated with ACY-1215. If more than 1/3 or 2/6 patients experience a DLT in Phase I, there will be no expansion.
Interventions
- DRUG ACY-1215
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-04-02 |
| Est. Completion | 2019-05-05 |
| Phase | Phase 1 |
Why NCT02091063 stopped before completion
NCT02091063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which ACY-1215 is the first listed.
NCT02091063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02091063 about?
NCT02091063 is a clinical study titled "ACY-1215 for Relapsed/Refractory Lymphoid Malignancies". This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215 for the treatment of patients with relapsed or refractory lymphoid malignancies. The target population will include patients with histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodg...
What is the current status of trial NCT02091063?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2014-04-02. Estimated completion is 2019-05-05.
What interventions are being tested in trial NCT02091063?
The interventions under investigation include: ACY-1215 (DRUG).
Who is sponsoring clinical trial NCT02091063?
This trial is sponsored by Jennifer Amengual, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02091063's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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