# SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

> **NCT05303519** · PHASE3 · RECRUITING · sponsor: **Nuvation Bio Inc.** · enrollment: 365 (estimated)

## Conditions studied

- 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

## Interventions

- **DRUG:** safusidenib
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05303519
- **Lead sponsor:** Nuvation Bio Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-06-05
- **Primary completion:** 2028-12-01
- **Final completion:** 2030-12-01
- **Target enrollment:** 365 (ESTIMATED)
- **Last updated:** 2026-03-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05303519

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05303519, "SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)". Retrieved via AI Analytics 2026-07-17 from https://api.ai-analytics.org/clinical/NCT05303519. Licensed CC0.

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