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SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

NCT05303519 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2026-03-05

No results posted yet for this study

Summary

This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.

The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.

The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.

Conditions

  • 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

safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.

DRUG

Placebo

Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.

Sponsors & Collaborators

  • AnHeart Therapeutics Inc.

    collaborator INDUSTRY

  • Nuvation Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2028-12-01
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303519 on ClinicalTrials.gov