clinical trial · NCT06087263
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.
M.D. Anderson Cancer Center·phase2·active not recruiting·n = 3
Gastrointestinal Stromal TumorsRegorafenib
brief summary
To learn if regorafenib can help to control the disease.
started
Jun 18, 2024
primary completion
Jul 1, 2032
completion
Jul 1, 2034
last updated
Jan 20, 2026
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 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol