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The Efficacy and Safety of Temozolomide in SDH-deficient GIST — GIST  

Gastrointestinal Stromal Tumors Clinical Trial

Official title:
A Phase 2 Study to Evaluate the Efficacy and Safety of Temozolomide in Advanced Gastrointestinal Stromal Tumor Patients With SDH Deficiency

Clinical Trial Summary

The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.

Clinical Trial Description

Wild type GISTs are less responsive to imatinib with a response rate of 23.1-44.6% and a median progressiion-free survival of 12.3-12.8 months. The efficacy of imatinib is limited in particular in SDH deficienctGIST with a reported response of 2%. Therefore, the development of a new therapeutic agents is urgently needed. Recently, a study of TKI-resistant SDH-deficient preclinical model showed that temozolomide, an alkylating agent, promotes DNA damage in tumor cells, leading to tumor cell killing. In a retrospective analysis, 2 out of 5 SDH deficient GIST patients treated with temozolomide showed partial response, suggesting its efficacy in this patient population. Based on these findings,The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients. In addition, for exploratory purposes, aim to investigate the efficacy and safety of temozolomide in KIT and PDGFRA wild-type GIST without SDH deficiency. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05661643
Study type Interventional
Source Asan Medical Center
Contact Min-Hee Ryu, MD, PhD
Phone 82-2-3010-5936
Email miniryu@amc.seoul.kr
Status Recruiting
Phase Phase 2
Start date June 28, 2023
Completion date December 31, 2027
View Details
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