Clin2
NCT05303519Possibly a fitRecruiting

Safusidenib for IDH1-mutant glioma after main treatment

GliomaAstrocytoma, Grade IVIDH1-mutant GliomaAstrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4Astrocytoma, IDH-Mutant, Grade 2OligodendrogliomaOligodendroglioma, IDH-Mutant and 1p/19q-Codeleted

Part of Blood & lymphatic, Cancer, Immune system & allergy clinical trials.

This Phase 3 trial tests safusidenib, a targeted medicine, to help stop or slow the return of certain brain tumors with an IDH1 mutation. It focuses on people after initial treatment (surgery and/or radiation and temozolomide), aiming to improve outcomes during maintenance therapy.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
365 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years or older when you sign consent.
  • Your tumor must be IDH1-mutant (specifically R132H or R132C for Part 1, or other R132 variants for later parts) confirmed by lab testing.
  • You must have a measurable tumor spot on brain MRI (large enough to measure) that fits “mainly enhancing” or “mainly non-enhancing” criteria.
  • You can usually have had no more than 2 prior treatments for regrowth (and timing matters).
  • If you’re in Parts 2–3, you also must have adequate blood/organ function and meet specific prior-treatment timing rules.

View the official record on ClinicalTrials.gov

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