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.

Status Recruiting

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 ;

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

• 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: Recruiting
• Phase: Phase 2
• Start date: June 18, 2024
• Completion date: July 1, 2034