Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465199
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Difluoromethylornithine DFMO and AMXT-1501 for Neuroblastoma CNS Tumors and Sarcomas
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 US 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 returningprogressing
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 returningprogressing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None