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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06465199
The ClinicalTrials.gov registry entry for NCT06465199 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 236-participant average among 94 other Neuroblastoma trials with a reported enrollment target (22% higher). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.