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NCT03459859 · ClinicalTrials.gov registry record · Phase 1
Pevonedistat and Low Dose Cytarabine in Adult Patients With AML and MDS
A Phase 1 study, sponsored by Justin Watts, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03459859: Completed Phase 1 study, sponsored by Justin Watts, MD.
NCT03459859 is a Phase 1 study that has completed, run by Justin Watts, MD. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459859, a Phase 1 study, has completed, sponsored by Justin Watts, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The investigators hypothesize that the combination of Pevonedistat/Low-Dose Cytarabine (LDAC) therapy will be tolerable, that a recommended phase 2 dose of Pevonedistat in combination with LDAC will be identified, and that the combination therapy will show evidence of clinical activity in adult patients with Relapsed/Refractory Acute Myelogenous Leukemia (AML) and Advanced Myelodysplastic Syndromes (MDS).
Primary Outcome
Rate of toxicity in study participants receiving at least one dose of combination Pevonedistat/LDAC protocol therapy, including determination of dose limiting toxicities (DLTs), serious adverse events (SAEs), and AEs. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Interventions
- DRUG Cytarabine
- DRUG Pevonedistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2021-06-25 |
| Phase | Phase 1 |
What the finished NCT03459859 record still lists
NCT03459859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Cytarabine is the first listed.
NCT03459859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459859 about?
NCT03459859 is a clinical study titled "Pevonedistat and Low Dose Cytarabine in Adult Patients With AML and MDS". The investigators hypothesize that the combination of Pevonedistat/Low-Dose Cytarabine (LDAC) therapy will be tolerable, that a recommended phase 2 dose of Pevonedistat in combination with LDAC will be identified, and that the combination therapy will show evidence of clinical activity in adult pati...
What is the current status of trial NCT03459859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-05-21. Estimated completion is 2021-06-25.
What interventions are being tested in trial NCT03459859?
The interventions under investigation include: Cytarabine (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT03459859?
This trial is sponsored by Justin Watts, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03459859's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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