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NCT06465199 · ClinicalTrials.gov registry record · Phase 1
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
A Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 289
- Enrollment target
- 6
- Study locations
NCT06465199: Recruiting Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Milton S. Hershey Medical Center.
NCT06465199 is a Phase 1 study of Neuroblastoma and Osteosarcoma that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 289 participants, above the 236-participant average among 94 other Neuroblastoma trials with a reported enrollment target (22% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06465199, a Phase 1 study of Neuroblastoma and Osteosarcoma, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 289 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: * Establish a recommended dose of AMXT 1501 in combination with DFMO * Test the safety and tolerability of AMXT 1501 in combination with DFMO * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing
Primary Outcome
To evaluate the safety, tolerability and recommended phase 2 dose (RP2D) of AMXT 1501 in combination with oral DFMO in pediatric and young adult participants.
Conditions Studied
Interventions
- DRUG AMXT 1501 Dicaprate
- DRUG Eflornithine (DFMO)
Study Locations (6)
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Hospital - Hartford
Florida
- St. Joseph's Children's Hospital - Tampa
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Pennsylvania
- Penn State Milton S. Hershey Medical Center and Children's Hospital - Hershey
Texas
- Children's Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2026-03-28 |
| Est. Completion | 2035-02 |
| Phase | Phase 1 |
What NCT06465199 shows while recruiting
NCT06465199 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, above the 236-participant average among 94 other Neuroblastoma trials with a reported enrollment target (22% higher).
The record links to 6 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 2 interventions - of which AMXT 1501 Dicaprate is the first listed.
NCT06465199 lists 6 locations in 6 states (Arkansas, Connecticut, Florida).
Frequently Asked Questions
What is clinical trial NCT06465199 about?
NCT06465199 is a clinical study titled "Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas". The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone o...
What is the current status of trial NCT06465199?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 289 participants. The study started on 2026-03-28. Estimated completion is 2035-02.
What conditions does trial NCT06465199 study?
This clinical trial studies the following conditions: Neuroblastoma, Osteosarcoma, Diffuse Intrinsic Pontine Glioma, Ewing Sarcoma, Atypical Teratoid/Rhabdoid Tumor.
What interventions are being tested in trial NCT06465199?
The interventions under investigation include: AMXT 1501 Dicaprate (DRUG), Eflornithine (DFMO) (DRUG).
Who is sponsoring clinical trial NCT06465199?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06465199 being conducted?
This trial has 6 study locations across Arkansas, Connecticut, Florida, Hawaii, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06465199's enrollment target sits among peer trials
289 14th of 94 higher than 81 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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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