# SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Source: https://onco.cc/trials/nct05303519/  
OnCo record `nct05303519` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Safusidenib in glioma & glioblastoma, now recruiting.

## Summary

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) is a phase 3 interventional study registered as NCT05303519, led by Nuvation Bio with AnHeart Therapeutics, and recruiting on the registry. Official title: A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma. Planned enrolment is 365 participants (estimated). The study started in 2023-06-05 and primary completion is expected in 2028-12-01. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: SIGMA
- Tags: ctgov-ingest
- Registry id: NCT05303519
- Phase: 3
- Setting: A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma
- Sponsor: Nuvation Bio
- Enrolled: 365

## Sources

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

## Connected records

- cancers: [Astrocytoma, IDH-mutant (grades 2 to 4)](https://onco.cc/cancers/idh-mutant-astrocytoma/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/)
- drugs: [Safusidenib](https://onco.cc/drugs/safusidenib/)
- companies: [Nuvation Bio](https://onco.cc/companies/nuvation-bio/)

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