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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.

Gastrointestinal Stromal Tumors Clinical Trial

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.

Clinical Trial Summary

To learn if regorafenib can help to control the disease.

Clinical Trial 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 1.1). Secondary Objectives: 1. RR by RECIST 1.1 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06087263
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Neeta Somaiah, M D
Phone (713) 792-3626
Email nsomaiah@mdanderson.org
Status Not yet recruiting
Phase Phase 2
Start date April 30, 2024
Completion date July 1, 2034
View Details
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