Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918640
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-06-06
Brief Title:
Lurbinectedin in FET-Fused Tumors
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Lurbinectedin in FET-Fusion Tumors LIFFT
Status:
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:
LiFFT
Brief Summary:
The purpose of this study is to find out if a drug called lurbinectedin the study drug is safe and effective at treating people with recurrent or relapsed solid tumors including Ewing sarcoma
Detailed Description:
In this study the investigators will test the activity of lurbinectedin as a targeted therapy for FET FUS Ewing Sarcoma Breakpoint Region 1 EWRS1 TATA-Box-Binding Protein Associated Factor 15 TAF15 Ewing sarcoma is driven by the Ewing Sarcoma-Friend Leukemia Integration 1 Transcription Factor EWS-FLI1 Lurbinectedin has been shown to inhibit EWS-FLI1 and Ewing Sarcoma-Wilms Tumor Gene 1 EWS-WT1 in preclinical models Therefore the goal of this study is to see if Lurbinectedin can be used to inhibit EWS-FLI1 EWS-WT1 or other FET fusion proteins to drive tumor responses in patients
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