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NCT04518345 · ClinicalTrials.gov registry record · Early Phase 1
TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia
A Early Phase 1 study, sponsored by Uma Borate.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT04518345: Completed Early Phase 1 study, sponsored by Uma Borate.
NCT04518345 is a Early Phase 1 study that has completed, run by Uma Borate. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04518345, a Early Phase 1 study, has completed, sponsored by Uma Borate.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase IB/II trial studies the best dose of TP-0903 and how well it works when given alone or with azacitidine in treating patients with FLT3 gene mutated acute myeloid leukemia. TP-0903 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TP-0903 alone or with azacitidine may kill more cancer cells.
Primary Outcome
Determine a tolerable dose of TP-0903 monotherapy for relapsed/refractory patients with FLT3 AML.
Interventions
- DRUG Azacitidine
- DRUG Dubermatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2021-12-22 |
| Phase | Early Phase 1 |
What the finished NCT04518345 record still lists
NCT04518345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT04518345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04518345 about?
NCT04518345 is a clinical study titled "TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia". This phase IB/II trial studies the best dose of TP-0903 and how well it works when given alone or with azacitidine in treating patients with FLT3 gene mutated acute myeloid leukemia. TP-0903 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drug...
What is the current status of trial NCT04518345?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2020-11-05. Estimated completion is 2021-12-22.
What interventions are being tested in trial NCT04518345?
The interventions under investigation include: Azacitidine (DRUG), Dubermatinib (DRUG).
Who is sponsoring clinical trial NCT04518345?
This trial is sponsored by Uma Borate, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04518345's enrollment target sits among peer trials
3 1949th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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