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.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Regorafenib	Given by PO

Timeline

• Start date: 2024-06-18
• Primary completion: 2032-07-01
• Completion: 2034-07-01
• First posted: 2023-10-17
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study