Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04067115
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-21
First Post:
2019-08-21
Brief Title:
SARC037 A Phase III Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
Sponsor:
Sarcoma Alliance for Research through Collaboration
Organization:
Sarcoma Alliance for Research through Collaboration
Study Overview
Official Title:
SARC037 A Phase III Study to Evaluate the Safety of Trabectedin Administered as a 1-Hour Infusion in Ewing Sarcoma Patients in Combination With Low Dose Irinotecan and 3-Deoxy-3-18F Fluorothymidine 18F-FLT Imaging
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
U01CA236220
Brief Summary:
This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma with a EWS-FLI1 mutation Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography PET scan to help evaluate the effect of treatment
Phase I was completed on 11162022 Phase II is actively recruiting
Phase I was completed on 11162022 Phase II is actively recruiting
Detailed Description:
Trabectedin and Irinotecan may inhibit the activity of this Ewing sarcoma mutation Trabectedin may suppress the proliferation of the gene involved in DNA damage response It blocks EWS-FLI1 by inactivating the fusion protein and silences the target genes
Irinotecan also suppresses the genes regulating the tumor cells generating DNA damage Together these drugs work in combination to suppress the gene regulating the tumor cells This combination may suppress the activity of the tumor regulating genes disrupting the activity of the genes The infusion of 18F-FLT in combination with a Positron Emission Tomography PET scan will demonstrate whether the target cells have been suppressed
Irinotecan also suppresses the genes regulating the tumor cells generating DNA damage Together these drugs work in combination to suppress the gene regulating the tumor cells This combination may suppress the activity of the tumor regulating genes disrupting the activity of the genes The infusion of 18F-FLT in combination with a Positron Emission Tomography PET scan will demonstrate whether the target cells have been suppressed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA236220 | NIH | None | httpsreporternihgovquickSearchU01CA236220 |