Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06087263
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-10-12
Brief Title:
Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets KIT Exon 17 18 or 14 Mutation and SDHB Deficient GIST in the Post-imatinib Second-line Setting
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets KIT Exon 17 18 or 14 Mutation and SDHB Deficient GIST in the Post-imatinib Second-line Setting
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if regorafenib can help to control the disease
Detailed Description:
Primary Objectives
To assess efficacy of regorafenib in second-line GIST for patients with KIT exon 17 18 or 14 mutation and SDHB deficient who progressed on imatinib as measured by PFS RECIST 11
Secondary Objectives
1 RR by RECIST 11 and CHOI criteria
2 Progression-free rate at 1 year and 2 years
3 Median OS and OS at 1 years 2years and 5 years
Exploratory objectives
1 Resistance mechanism ctDNA analysis in patients initially responding to regorafenib
2 Response data on next line of treatment post regorafenib
To assess efficacy of regorafenib in second-line GIST for patients with KIT exon 17 18 or 14 mutation and SDHB deficient who progressed on imatinib as measured by PFS RECIST 11
Secondary Objectives
1 RR by RECIST 11 and CHOI criteria
2 Progression-free rate at 1 year and 2 years
3 Median OS and OS at 1 years 2years and 5 years
Exploratory objectives
1 Resistance mechanism ctDNA analysis in patients initially responding to regorafenib
2 Response data on next line of treatment post regorafenib
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 |
|---|---|---|---|
| NCI-2023-08857 | OTHER | NCI-CTRP Clinical Trials Registry | None |