Trial · NCT05303519
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| 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 |
| Secondary | Part 1: Duration of Response (DOR) assessed by the Investigator | from the first dose of study drug until the date of first documented disease progression, average 2 years | DOR, defined as the time from the first documentation of objective response (CR, PR, or MR) to the date of the first documentation of disease progression per RANO-HGG/RANO-LGG as applicable, or death (by any cause in the absence of progression), for participants with confirmed objective response, as assessed by the Investigator |
| Secondary | Part 1: Disease control rate (DCR) assessed by the Investigator | from the first dose of study drug until the date of first documented disease progression, average 2 years | DCR, defined as the proportion of patients with a best overall response of CR, PR, Stable Disease (SD), or Minor Response (MR) per RANO-HGG/RANO-LGG as applicable, as assessed by the Investigator |
| Secondary | Part 1: Progression free survival (PFS) assessed by the Investigator | from the first dose of study drug until the date of first documented disease progression, average 2 years | PFS, defined as the time from the first dose of study drug to the date of the first documented disease progression per RANO-HGG/RANO-LGG as applicable, or death (by any cause in the absence of disease progression), as assessed by the Investigator |
| Secondary | Part1: Time to Response (TTR) assessed by the Investigator. | From the first dose of study drug until the date of first documented objective response, average 2 years | TTR, the time from the first dose of study drug to the first documentation of objective response (CR, PR, or MR) per RANO-HGG/RANO-LGG as applicable, for participants with confirmed objective response, as assessed by the Investigator. |
| Secondary | Part 1: Overall Survival (OS) | from the first dose of study drug to date of death, average 7 years | OS, defined as the time from randomization to death from any cause. Participants without death information at the analysis cutoff date will be censored at last date known to be alive. |
| Secondary | Part 2: Overall Survival (OS) | from randomization to date of death, average 7 years | OS, defined as the time from randomization to death from any cause. |
| Secondary | Part 2: PFS assessed by the Investigator. | from randomization until the date of first documented disease progression, average 2 years | PFS, defined as the time from randomization to the date of the first documented disease progression per RANO 2.0, or death (by any cause in the absence of disease progression), as assessed by the Investigator. |
| Secondary | Part2: Time to Next Intervention (TTNI) by Investigator assessment | From randomization until the date of next treatment, average 2 years | TTNI, defined as the time from randomization to initiation of the first new anticancer therapy, or death due to any cause, whichever comes earlier. Participants who neither initiated new anticancer therapy nor have died at the analysis cutoff date will be censored at the last date known to be alive. |
| Secondary | Part2: DCR assessed by BICR and by the Investigator | from randomization until the date of first documented disease progression, average 2 years | DCR, defined as the proportion of participants with a best overall response of CR, PR, MR, or SD per RANO 2.0, as assessed by the Investigator and BICR |
| Secondary | Part2: ORR | from randomization until the date of first documented disease progression, average 2 years | ORR, defined as the proportion of participants with the confirmed best overall response of CR, PR, or MR per RANO 2.0, as assessed by BICR and the Investigator. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT05303519/registered