SIGMA Study: Safusidenib for IDH1-Mutant Glioma
This study, called SIGMA, is testing a drug called safusidenib for people with certain types of glioma (a brain tumor) that have a specific genetic change called an IDH1 mutation. The study aims to see how safe and effective safusidenib is. Part 1, which is fully enrolled, looked at different doses of safusidenib. Part 2 will compare safusidenib to a placebo (an inactive substance) in about 300 participants who have already received standard treatments like radiation or chemotherapy. Researchers will measure how long people live without their cancer getting worse and how many people see their tumors shrink. You may be eligible if you are 18 or older and have a Grade 2, 3, or 4 IDH1-mutant astrocytoma.
- Study design
- This is a multi-part study. Part 2, which is currently recruiting, is a randomized, double-blind (meaning neither you nor your doctor will know if you're getting the study drug or placebo) study comparing safusidenib to placebo in about 300 participants.
- What's involved
- You would take safusidenib or placebo orally every day in 28-day cycles. Treatment continues until your disease progresses or you experience side effects that make you stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for an average of 2 years to track side effects and disease progression. Long-term survival follow-up will also be conducted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
At a glance
Conditions
Where it's being run
61 sites across 38 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs)From participants sign ICF to 30 days after last dose，average 2 years
calculate Percentage and numbers of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed by CTCAE 5.0
- Part 2: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0From randomization until the date of first documented disease progression, average 2 years
PFS is defined as the time from randomization to the date of the first documented disease progression assessed by BICR per RANO 2.0 or death (by any cause in the absence of disease progression).
- Part 3 Objective Response Rate (ORR) (Complete Response (CR), Partial Response (PR) and Minor Response (MR)) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0From the first dose of study drug until the date of first documented disease progression, average 18 months