NCT05303519Phase 3Recruiting

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-12-01Estimated

Enrollment · participants365Estimated

Source updated2026-08-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-01-27 · 4 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

+ After

Measure: Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs) Measure: Part 2: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0 Measure: 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) 2.0

Planned enrollment increased by 240 participants

− Before

~~125 participants (planned)~~

+ After

365 participants (planned)

Primary completion date changed

− Before

~~1 Dec 2027~~

+ After

1 Dec 2028

Phase changed

− Before

~~PHASE2~~

+ After

PHASE3

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Study details

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

Treatments or interventions studied

safusidenibDrugAlso known as DS-1001b, AB-218
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs); description: calculate Percentage and numbers of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed by CTCAE 5.0; timeFrame: From participants sign ICF to 30 days after last dose，average 2 years; measure: Part 2: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0; description: 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).; timeFrame: From randomization until the date of first documented disease progression, average 2 years; measure: 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) 2.0; timeFrame: From the first dose of study drug until the date of first documented disease progression, average 18 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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