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NCT05500508 · ClinicalTrials.gov registry record · Phase 1
Oral AMXT 1501 Dicaprate in Combination With IV DFMO
A Phase 1 study, sponsored by Aminex Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT05500508: Clinical Trial Phase 1 study, sponsored by Aminex Therapeutics.
NCT05500508 is a Phase 1 study that was terminated before completion, run by Aminex Therapeutics. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05500508, a Phase 1 study, was terminated before completion, sponsored by Aminex Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.
Primary Outcome
Indicate Number of patients with DLTs in AMXT1501 in combination with IV DFMO in patients with advanced cancer to determine the RP2D within the duration of the dose escalation period of the study as defined by the DLT definition of the protocol from baseline to end of Cycle 1
Interventions
- DRUG DFMO
- DRUG AMXT1501
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2024-12-12 |
| Phase | Phase 1 |
Why NCT05500508 stopped before completion
NCT05500508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which DFMO is the first listed.
NCT05500508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05500508 about?
NCT05500508 is a clinical study titled "Oral AMXT 1501 Dicaprate in Combination With IV DFMO". A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.
What is the current status of trial NCT05500508?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-11-29. Estimated completion is 2024-12-12.
What interventions are being tested in trial NCT05500508?
The interventions under investigation include: DFMO (DRUG), AMXT1501 (DRUG).
Who is sponsoring clinical trial NCT05500508?
This trial is sponsored by Aminex Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05500508's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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