Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
← catalyst calendarNCT07712757 · readout ≤ 1,016 d
Sponsored by Nuvation Bio Inc. (industry) · NUVB — their whole pipeline →.
Phase
Phase 3
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
140estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Mar 2027 | estimated | When the study began enrolling |
| Primary completion | May 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation
- Astrocytoma IDH Mutant Grade 2
- Oligodendroglioma
- Oligodendroglioma IDH-mutant and 1p/19q-codeleted
- IDH-mutant Gliomas
Interventions
- Drug: Safusidenib
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0
measured From the date of randomization until the date of first documented disease progression, approximately 30 months
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