Ewing Sarcoma Clinical Trial
Official title:
A Dose Escalation Study Using Difluoromethylornithine (DFMO) and AMXT-1501 Followed by a Randomized Controlled Trial of DFMO With or Without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas
The purpose of this study is to evaluate the investigational drug AMXT 1501 (a pill taken by mouth) in combination with the drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). 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 for infusion - Test the safety and tolerability of AMXT 1501 in combination with DFMO for infusion in patients with cancer - 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
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