A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours
← catalyst calendarNCT07441707 · readout in 1,442 d
Sponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
6estimated
Sites
6
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-03 | actual | When the study began enrolling |
| Primary completion | 2030-07-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-07-31 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Low-grade Glioma
Intervention
- Drug: Tovorafenib — also filed as Ojemda®
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants experiencing Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
measured From first dose until 30 days post-treatment
Percentage of participants experiencing Serious Adverse Events (SAEs) and AESIs
measured Up to 4 years from first dose, including post-treatment monitoring
Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC₀-t) of tovorafenib following a single dose
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC₀-inf) of tovorafenib following a single dose
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Maximum observed plasma concentration (Cmax) of tovorafenib following a single dose
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Time to maximum plasma concentration following a single dose (Tmax) of tovorafenib
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Terminal half-life (t½) of tovorafenib following a single dose
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval at steady-state (AUC₀-tau) of tovorafenib
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Maximum plasma concentration at steady-state (CmaxSS) of tovorafenib
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Minimum plasma concentration at steady-state (CminSS) of tovorafenib
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Average Plasma Concentration at Steady-State (CavSS) of tovorafenib
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Time to maximum plasma concentration at steady-state (TmaxSS) of tovorafenib
measured From Cycle 1 Day 1 to Cycle 2 Day 8 (each cycle is 28 days)
Permalink · IPN.PA's whole pipeline · Catalyst calendar · Every registered study · What changed