Trial · NCT05303519
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
NCT05303519, Phase 3, Recruiting, Nuvation Bio Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance). Trials, record NCT05303519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05303519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
- NCT number
- NCT05303519
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 365 participants, estimated
- Lead sponsor
- Nuvation Bio Inc.
- 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
- safusidenib, Placebo
- First posted
- 2022-03-31
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | Part 2: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0 | From 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). |
| Primary | 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 | From the first dose of study drug until the date of first documented disease progression, average 18 months | |
| Secondary | Part 1: Cmax of safusidenib | on Cycle 1 Day 1 and Day 8 (every cycle is 28 days) | Peak Plasma Concentration (Cmax) |
| Secondary | Part 1: Tmax of safusidenib | on Cycle 1 Day 1 and Day 8 (every cycle is 28 days) | the time for safusidenib to reach Cmax |
| Secondary | Part 1: AUC8h of safusidenib | on Cycle 1 Day 1 and Day 8 (every cycle is 28 days) | Area under the plasma concentration curve (AUC) from time 0 to 8 hours |
| Secondary | Part 1 : AUC12h of safusidenib | on Cycle 1 Day 1 and Day 8 (every cycle is 28 days) | Area under the plasma concentration curve (AUC) from time 0 to 12 hours |
| Secondary | Part 1: AUC24h [QD only] of safusidenib | on Cycle 1 Day 1 and Day 8 (every cycle is 28 days) | Area under the plasma concentration curve (AUC) from time 0 to 24h hours for 500mg qd cohort |
| Secondary | Part 1 : Ctrough of safusidenib | on Days 2, 3, 4, 6, 8, 9 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 6 and 8 (every cycle is 28 days) | Lowest plasma concentration reached after AB-218 administration |
| Secondary | Part 1: Overall Response Rate (ORR) assessed by the investigator | from the first dose of study drug until the date of first documented disease progression, average 2 years | ORR (defined as the proportion of participants with the best overall confirmed response of Complete Response (CR), Partial Response (PR) or Minor Response (MR)\[for RANO-HGG/RANO LGG\] according to the appropriate tumor response criteria) as assessed by the Investigator |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05303519
GET https://conductscience.org/api/trials/v1/NCT05303519/registered?page=2