Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414434
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
BTX-A51 in Patients with Liposarcoma
Sponsor:
Michael Wagner
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of BTX-A51 in Patients with Metastatic Andor Recurrent Liposarcomas Characterized by MDM2 Amplifications
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This study is testing if the recommended dose of BTX-A51 is safe and tolerable in participants with liposarcoma
The name of the study drug used in this research study is
-BTX-A51 a type of kinase inhibitor
The name of the study drug used in this research study is
-BTX-A51 a type of kinase inhibitor
Detailed Description:
This is a single arm pilot study assessing the safety and preliminary exploration of BTX-A51 in participants with metastatic andor recurrent liposarcomas characterized by Murine Double Minute Clone 2 MDM2 amplifications BTX-A51 works in a different way from currently approved therapies used to treat liposarcoma by blocking proteins called CK1α and CDK9
The US Food and Drug Administration FDA has not approved BTX-A51 as a treatment for Liposarcoma
The research study procedures include screening for eligibility Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans or Positron Emission Tomography PET scans blood tests and tumor biopsies
Participants will receive study treatment for as long as there are no serious side effects and disease does not get worse Participants will be followed for 1 year after the last dose of BTX-A51
It is expected that about 12 people will take part in this research study
Edgewood Oncology is supporting this research study by providing the study drug
The US Food and Drug Administration FDA has not approved BTX-A51 as a treatment for Liposarcoma
The research study procedures include screening for eligibility Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans or Positron Emission Tomography PET scans blood tests and tumor biopsies
Participants will receive study treatment for as long as there are no serious side effects and disease does not get worse Participants will be followed for 1 year after the last dose of BTX-A51
It is expected that about 12 people will take part in this research study
Edgewood Oncology is supporting this research study by providing the study drug
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