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Recruiting Phase 1Phase 2 Interventional

Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas

ClinicalTrials.gov ID: NCT06465199

Public ClinicalTrials.gov record NCT06465199. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II Study Using Eflornithine (DFMO) and AMXT 1501 for Relapsed and Refractory Neuroblastoma, CNS Tumors, and Sarcomas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06465199
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
289 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 26 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 12, 2026
Primary completion
Apr 30, 2033
Completion
Apr 30, 2035
Last update posted
Aug 11, 2026

2026 – 2035

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
University of Alabama/Children's of Alabama Birmingham Alabama 35233 Recruiting
Arkansas Children's Hospital Little Rock Arkansas 72202 Recruiting
Connecticut Children's Hospital Hartford Connecticut 06106 Recruiting
University of Florida Gainesville Florida 32611 Recruiting
Nicklaus Children's Hospital Miami Florida 33155 Recruiting
Arnold Palmer Hospital for Children Orlando Florida 32806 Recruiting
St. Joseph's Children's Hospital Tampa Florida 33614 Recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96813 Recruiting
Children's Mercy Hospitals and Clinics Kansas City Kansas 64108 Recruiting
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 Recruiting
Hackensack University Medical Center Hackensack New Jersey 07601 Recruiting
Penn State Milton S. Hershey Medical Center and Children's Hospital Hershey Pennsylvania 17033 Recruiting
Monroe Carrell Jr. Children's Hospital at Vanderbilt Nashville Tennessee 37232 Recruiting
Children's Medical Center Dallas Texas 75235 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06465199, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06465199 live on ClinicalTrials.gov.

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