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NCT02141828 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene
A Phase 1 study, sponsored by Epizyme.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02141828: Completed Phase 1 study, sponsored by Epizyme.
NCT02141828 is a Phase 1 study that has completed, run by Epizyme. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02141828, a Phase 1 study, has completed, sponsored by Epizyme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of patients with MLL-rearranged leukemias.
Primary Outcome
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 as determined by incidence of protocol-specified dose-limiting adverse events.
Interventions
- DRUG EPZ-5676
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02141828 record still lists
NCT02141828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which EPZ-5676 is the first listed.
NCT02141828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02141828 about?
NCT02141828 is a clinical study titled "A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene". A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L plays an important role in th...
What is the current status of trial NCT02141828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2014-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02141828?
The interventions under investigation include: EPZ-5676 (DRUG).
Who is sponsoring clinical trial NCT02141828?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02141828's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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