OncoMatch/Clinical Trials/NCT05661643
The Efficacy and Safety of Temozolomide in SDH-deficient GIST
Is NCT05661643 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05661643 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received tyrosine kinase inhibitor.
Does this trial require KIT?
Yes, KIT wild-type is a required biomarker for enrollment.
Does this trial require PDGFRA?
Yes, PDGFRA wild-type is a required biomarker for enrollment.
Are patients with NTRK1 alterations eligible?
No. NTRK1 fusion is an exclusion criterion.
Are patients with NTRK2 alterations eligible?
No. NTRK2 fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages