SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Glioma · Astrocytoma, Grade IV · IDH1-mutant Glioma · Astrocytoma, IDH-Mutant, Grade 3 · Astrocytoma, IDH-Mutant, Grade 4 · Astrocytoma, IDH-Mutant, Grade 2 · Oligodendroglioma · Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 3
- Patients
- 365 (planned)
- Started
- Jun 5, 2023
- Main results expected
- Dec 1, 2028
- Fully finished
- Dec 1, 2030
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured over: From participants sign ICF to 30 days after last dose，average 2 years
Part 2: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0
Measured over: From randomization until the date of first documented disease progression, average 2 years
Part 3 Objective Response Rate (ORR) (Complete Response (CR), Partial Response (PR) and Minor Response (MR)) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0
Measured over: From the first dose of study drug until the date of first documented disease progression, average 18 months
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT05303519 · record last updated 2026-10-19 · checked 2026-11-09 15:47 UTC