Trial · NCT07441707
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 | Percentage of participants experiencing Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) | From first dose until 30 days post-treatment | |
| Primary | Percentage of participants experiencing Serious Adverse Events (SAEs) and AESIs | Up to 4 years from first dose, including post-treatment monitoring | An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. |
| Primary | Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC₀-t) of tovorafenib following a single dose | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | AUC₀-t represents the total drug exposure over time from administration until the last measurable concentration after a single dose of tovorafenib. |
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC₀-inf) of tovorafenib following a single dose | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | AUC₀-inf estimates the total drug exposure from administration to infinite time, extrapolating beyond the last measurable concentration. |
| Primary | Maximum observed plasma concentration (Cmax) of tovorafenib following a single dose | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | Cmax is the highest concentration of tovorafenib observed in plasma after a single dose |
| Primary | Time to maximum plasma concentration following a single dose (Tmax) of tovorafenib | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | Tmax refers to the time point at which the maximum observed plasma concentration of tovorafenib is reached following a single dose |
| Primary | Terminal half-life (t½) of tovorafenib following a single dose | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | Terminal half-life (t½) will be assessed following a single dose of tovorafenib. |
| Primary | Area under the plasma concentration-time curve over the dosing interval at steady-state (AUC₀-tau) of tovorafenib | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | AUC₀-tau refers to the area under the plasma concentration-time curve over the dosing interval (tau) during steady-state conditions, representing total drug exposure per dosing cycle |
| Primary | Maximum plasma concentration at steady-state (CmaxSS) of tovorafenib | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | CmaxSS refers to the maximum observed plasma concentration of tovorafenib measured during steady-state conditions, after repeated dosing when drug input and elimination have reached equilibrium. |
| Primary | Minimum plasma concentration at steady-state (CminSS) of tovorafenib | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | CminSS refers to the lowest observed plasma concentration of tovorafenib during steady-state conditions, reflecting trough levels between doses. |
| Primary | Average Plasma Concentration at Steady-State (CavSS) of tovorafenib | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | CavSS refers to the average plasma concentration of tovorafenib over the dosing interval during steady-state conditions, calculated from multiple time points |
| Primary | Time to maximum plasma concentration at steady-state (TmaxSS) of tovorafenib | From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days) | TmaxSS refers to the time point at which the maximum plasma concentration of tovorafenib is observed during steady-state conditions |
| Secondary | Change in total tumor volume over time | Every 12 weeks from Cycle 1 Day 1 up to end of treatment (approximately 24 months). | Assessment based on MRI imaging data to evaluate tumor volume and its evolution during treatment. |
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/NCT07441707/registered