Trial · NCT07206849
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Stratum A | 6 years | Estimate the progression-free survival (PFS) distribution for pediatric and young adult patients (age: ≥12 months and ≤39 years) with newly-diagnosed BRAFV600 mutant HGG (Stratum A) who receive tovorafenib monotherapy post RT compared to molecularly-stratified, matched historical controls. |
| Secondary | Overall Survival Stratum A | 6 years | Estimate the overall survival (OS) distribution for pediatric and young adult patients with newly-diagnosed BRAFV600 mutant HGG (Stratum A) who receive tovorafenib post RT compared to molecularly-stratified, matched historical controls. |
| Secondary | OS Stratum B | 6 years | Describe OS for pediatric and young adult patients newly diagnosed with DIPG or DMG harboring MAPK pathway alterations who receive tovorafenib post RT (Stratum B). |
| Secondary | PFS Stratum B | 6 years | Describe PFS for pediatric and young adult patients newly diagnosed with HGG harboring MAPK alterations not included in Stratum A who receive tovorafenib post RT (Stratum B). |
| Secondary | OS Stratum B | 6 years | Describe the OS for pediatric and young adult patients newly diagnosed with primary spinal cord HGG harboring a MAPK alteration who receive tovorafenib post RT (Stratum B). |
| Secondary | Establish the RP2D of tovorafenib - Stratum C | At the end of Cycle 1 (each cycle is 28 days) | Evaluate the feasibility of administration of tovorafenib post craniospinal RT in pediatric and young adult patients with newly diagnosed, metastatic HGG harboring a MAPK alteration (Stratum C). |
| Secondary | OS Stratum C | 6 years | Describe OS for pediatric and young adult patients with newly-diagnosed, metastatic HGG who receive tovorafenib post RT (Stratum C). |
| Secondary | ORR | 6 years | Evaluate the radiographic objective response rate (ORR \[complete response (CR) + partial response (PR)\]) to tovorafenib treatment post RT in pediatric and young adult patients with newly diagnosed HGG and DIPG/DMG that harbor MAPK alterations (all Strata). |
| Secondary | Number of participants with tovorafenib-related adverse events as assessed by CTCAE v5.0 | From Day 1 of protocol treatment through 30 days following end of protocol treatment | Assess and further characterize the safety and toxicity of post-RT tovorafenib in pediatric and young adult patients newly diagnosed with HGG, including DIPG. This will be achieved by calculating the number of participants with, as well as frequency and severity of, tovorafenib-related Adverse Events as assessed by CTCAE v5.0. |
| Secondary | Correlation between genomic status, recurrence, radiographic response | 6 years | Explore longitudinal associations of genomic, transcriptomic, epigenetic, and/or immunologic alterations of tumor at diagnosis, recurrence, or autopsy with radiographic response, advanced neuro-imaging measures, and patient-reported outcomes. |
| Secondary | Evaluate Health-Related Quality of Life Outcomes | 6 years | Evaluate health-related quality of life outcomes of pediatric and young adult patients newly-diagnosed with HGG, including DIPG, treated with tovorafenib, by patient and/or parent reporting at key timepoints in therapy using the patient reported outcomes measurement information system (PROMIS) survey which will be completed by consenting participants every other cycle for the length of their treatment (all Strata). |
| Secondary | PFS Stratum B | 6 years | Describe the PFS for pediatric and young adult patients newly diagnosed with primary spinal cord HGG harboring a MAPK alteration who receive tovorafenib post RT (Stratum B). |
| Secondary | PFS Stratum C | 6 years | Describe PFS for pediatric and young adult patients with newly-diagnosed, metastatic HGG who receive tovorafenib post RT (Stratum C). |
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.
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GET https://conductscience.org/api/trials/v1/NCT07206849/registered