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 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

Trial Details

NCT ID
NCT06465199
Phase
PHASE1 / PHASE2
Sponsor
Milton S. Hershey Medical Center
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • Eflornithine (DFMO)
  • AMXT 1501 Dicaprate
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Hartford, Connecticut, United States|41.76371,-72.68509
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

  • All participants : Must be a maximum of 26 years of age at diagnosis
  • Age at enrollment by Phase:
  • Safety Run-in (Dose level 1)-The first three (3) participants enrolled will be ≥ 12 years of age at enrollment. Once evaluated for safety by DSMB, …
  • Phase I and II: ≤ 26 years of age at diagnosis.

For full eligibility, visit ClinicalTrials.gov.

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