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Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
NCT06465199 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 277 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06465199 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Arkansas, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06465199?
The interventions under investigation include: AMXT 1501 Dicaprate (DRUG), Eflornithine (DFMO) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06465199?
This trial is sponsored by Milton S. Hershey Medical Center, which has 277 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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