Actively Recruiting
The Efficacy and Safety of Temozolomide in SDH-deficient GIST
Led by Asan Medical Center · Updated on 2026-04-07
29
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.
CONDITIONS
Official Title
The Efficacy and Safety of Temozolomide in SDH-deficient GIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older at the time of informed consent
- Histologically confirmed GIST with positive CD117 and DOG-1 markers
- Wild type GIST without KIT or PDGFRA gene mutations confirmed by sequencing
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Adverse events from prior treatments resolved to grade 0 or 1 per NCI-CTCAE v5.0
- At least one measurable tumor lesion per RECIST v1.1
- Adequate bone marrow, liver, kidney, and other organ function before adjuvant imatinib treatment, including neutrophils >1500/mm3, platelets >100,000/mm3, hemoglobin >8.0 g/dL, total bilirubin <1.5 times upper limit of normal, AST/ALT <2.5 times upper limit of normal, creatinine <1.5 times upper limit of normal
- Life expectancy of at least 12 weeks
- Disease progression or discontinuation of first-line imatinib due to intolerable toxicity
- Washout period from previous tyrosine kinase inhibitors or chemotherapy of more than 4 times the half-life
- Signed written informed consent
You will not qualify if you...
- Presence of KIT or PDGFRA gene mutations in GIST confirmed by sequencing
- Pregnant or breastfeeding women of child-bearing potential
- Women or men unwilling to use effective contraception during the study and for at least 6 months after last study drug dose
- History within 6 months before enrollment of severe heart or vascular conditions including myocardial infarction, unstable angina, bypass surgery, NYHA class III or IV heart failure, stroke or transient ischemic attack, or severe arrhythmia requiring treatment
- Uncontrolled infections
- Acute or chronic liver disease or impairment except stable chronic hepatitis B
- Acute or chronic medical or psychiatric conditions or lab abnormalities that would interfere with study participation
- Known HIV infection
- History of other primary malignancies currently clinically significant or requiring active treatment
- Alcohol or substance abuse disorder
- Patients with NTRK fusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Seoul, South Korea, 138-736
Actively Recruiting
Research Team
M
Min-Hee Ryu, MD, PhD
CONTACT
H
Hyung-Don Kim, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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