Clinical trialNCT06465199RecruitingPhase 1/PHASE2Interventional

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

SponsorMilton S. Hershey Medical CenterEnrollment289Atypical Teratoid/Rhabdoid TumorDIPG Brain TumorDiffuse Intrinsic Pontine GliomaEmbryonal Tumor With Multilayered RosettesEwing SarcomaNeuroblastoma+1 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Giselle Saulnier Sholler, MD
Penn State Health Children's Hospital
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama/children'S of Alabama
Birmingham, Alabama, United States
Elizabeth Alva
Recruiting
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Kevin Bielamowicz
Recruiting
Connecticut Children'S Hospital
Hartford, Connecticut, United States
Michael Isakoff
Recruiting
University of Florida
Gainesville, Florida, United States
Joanne Lagmay
Recruiting
Nicklaus Children'S Hospital
Miami, Florida, United States
Guillermo De Angulo
Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Jamie Libes-Bander
Recruiting
St. Joseph'S Children'S Hospital
Tampa, Florida, United States
Don Eslin
Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Kelley Hutchins
Recruiting
Children'S Mercy Hospitals and Clinics
Kansas City, Kansas, United States
Kevin Ginn
Recruiting
Cardinal Glennon Children'S Medical Center
St Louis, Missouri, United States
William Ferguson
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Derek Hanson
Recruiting
Penn State Milton S. Hershey Medical Center and Children'S Hospital
Hershey, Pennsylvania, United States
Valerie Brown
Recruiting
Monroe Carrell Jr. Children'S Hospital at Vanderbilt
Nashville, Tennessee, United States
Daniel Benedetti
Recruiting
Children'S Medical Center
Dallas, Texas, United States
Tanya Watt
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AMXT 1501 DicaprateEflornithine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 13 May 2026
Primary completion: 31 May 2033
Completion: 31 May 2035
Last update posted: 12 Aug 2026
Registered enrollment: 289
Registry id: NCT06465199

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.