Trial · NCT04164901
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to approximately 30 months | PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier. |
| Secondary | Time to Next Intervention (TTNI) | Up to approximately 3 years | TTNI is defined as the time from randomization to the initiation of the first subsequent anticancer therapy (including vorasidenib, for subjects randomized to placebo who subsequently cross over) or death due to any cause. |
| Secondary | Tumor Growth Rate (TGR) | every 6 months, up to 2 years and 9 months | Calculated as the mean of the percentage change in tumor volume every 6 months |
| Secondary | Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC) | approximatively 30 months | OR is defined as a best overall response (BOR) of Complete Response, Partial Rresponse, or minor Response as assessed by the BIRC per the modified Response Assessment in Neuro-oncology for Low-grade Gliomas (RANO-LGG). |
| Secondary | Complete Response (CR) and Partial Response (PR) by BIRC | Approximatively 30 months | CR and PR is defined as a BOR of CR or PR as assessed by BIRC per the modified RANO-LGG |
| Secondary | Time to Response (TTR) by BIRC | Approximatively 30 months | TTR is defined as the time from the date of randomization to the date of first documented CR, PR, or mR by BIRC per the modified RANO-LGG |
| Secondary | Time to CR+PR by BIRC | Approximatively 30 months | Time to CR+PR is defined as defined as the time from the date of randomization to the date of first documented CR or PR for subjects with CR or PR per the modified RANO-LGG (by BIRC) |
| Secondary | Duration of Response (DoR) | Approximatively 30 months | DoR is defined as the time from the date of first documented CR, PR, or mR to the date of death due to any cause or date of first documented radiographic Prgressive Disease, whichever occurred earlier |
| Secondary | Duration of CR+PR | Approximatively 30 months | Duration of CR+PR is defined as the time from the date of first documented CR or PR to the date of death due to any cause or first documented radiographic PD, whichever occurred earlier |
| Secondary | Overall Survival (OS) | Approximatively 30 months | OS wad defined as the time from the date of randomization to the date of death due to any cause or data cutoff. |
| Secondary | Progression-Free Survival (PFS) by the Investigator | Approximatively 30 months | PFS as assessed by the Investigator per the modified RANO-LGG |
| Secondary | Health-Related Quality of Life (FACT-Br) | Approximatively 30 months | Health-Related Quality of Life (HRQoL) Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 50-item measure comprising the following subscales: Physical Well-Being, Functional Well-Being, Emotional Well-Being, and Social Well-Being subscales from the FACT-General (FACT-G), with the addition of a 23-item brain tumor-specific subscale. These subscales are summed to provide a total score. The total score is given at the end of treatment and total scores range from 0 to 200. Higher scores indicate a better HRQoL |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04164901/registered