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NCT04139434 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML
A Phase 1 study, sponsored by Newave Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04139434: Completed Phase 1 study, sponsored by Newave Pharmaceutical.
NCT04139434 is a Phase 1 study that has completed, run by Newave Pharmaceutical. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04139434, a Phase 1 study, has completed, sponsored by Newave Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Interventions
- DRUG LP-108
- DRUG LP-108 and azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2025-12-19 |
| Phase | Phase 1 |
What the finished NCT04139434 record still lists
NCT04139434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which LP-108 is the first listed.
NCT04139434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04139434 about?
NCT04139434 is a clinical study titled "Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML". A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelom...
What is the current status of trial NCT04139434?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-07-06. Estimated completion is 2025-12-19.
What interventions are being tested in trial NCT04139434?
The interventions under investigation include: LP-108 (DRUG), LP-108 and azacitidine (DRUG).
Who is sponsoring clinical trial NCT04139434?
This trial is sponsored by Newave Pharmaceutical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04139434's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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