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Safusidenib for glioma with an IDH1 gene change

Official title: SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.

The trial team last updated this record on .

The short version

This study is testing a drug called safusidenib in people whose glioma: A tumor that starts in the glial cells. Those are the support cells of the brain and spinal cord. Gliomas are given a grade from 1 to 4. The grade says how the tumor is expected to act. See the glossary has an IDH gene change: A small change in a tumor's IDH gene. It is the first thing your team looks at when naming an adult glioma, and it can affect which treatments are offered. Your pathology report says whether your tumor has it. See the glossary gene change.

Read our full plain-language summary

What the trial team says

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.

From the trial's own listing on ClinicalTrials.gov.

Key facts

Registry number
NCT05303519
Stage of testing
Phase 3
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

Where it is running

This trial lists 61 sites.

How to use this

Talk to your care team first. They know your history and can tell you whether this trial is worth your time.

Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.

See the full listing on ClinicalTrials.gov

This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.