OncoMatch/Clinical Trials/NCT05661643
The Efficacy and Safety of Temozolomide in SDH-deficient GIST
Is NCT05661643 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Temozolomide capsule for gastrointestinal stromal tumors.
Treatment: Temozolomide capsule — The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT wild-type
Required: PDGFRA wild-type
Excluded: NTRK1 fusion
Excluded: NTRK2 fusion
Excluded: NTRK3 fusion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor (imatinib) — palliative 1st line
Disease progression or discontinuation of treatment due to intolerable toxicity at least with palliative 1st line imatinib
Lab requirements
Blood counts
neutrophil >1,500/mm3; platelet > 100,000/mm3; hemoglobin >8.0 g/dl
Kidney function
creatinine <1.5 x uln
Liver function
total bilirubin < 1.5 x uln; ast/alt < 2.5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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