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Secondary endpoints: details revised at 5 of 5 entries
Study arms: 5 to 4
Study title expanded, about 1 word
MinorCollaborators: 1 to 2v6
NotableStart date: Feb 1, 2025 to Oct 1, 2025v5
NotableStart date: Dec 1, 2024 to Feb 1, 2025
Primary completion date: Dec 2032 to Feb 2033
Study completion date: Dec 2034 to Feb 2035
v4
NotableStart date: Sep 1, 2024 to Dec 1, 2024
Primary completion date: Jul 2032 to Dec 2032
Study completion date: Jul 2034 to Dec 2034
v3
NotableStart date: Jul 2024 to Sep 1, 2024v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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