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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.

Phase 2RecruitingAsan Medical CenterNCT05661643Data as of May 2026

Treatment: Temozolomide capsuleThe goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.

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Extracted 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

Min 1 prior line

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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