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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 is a Phase 1 study that was terminated before completion, run by Jennifer Amengual. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02091063
The ClinicalTrials.gov registry entry for NCT02091063 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jennifer Amengual, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACY-1215 is the first listed.
NCT02091063 reports 0 study locations.
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.
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