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Trial · NCT07441707

A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours

NCT07441707, Phase 1, Active not recruiting, Ipsen

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours. Trials, record NCT07441707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07441707

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours
NCT number
NCT07441707
Status
Active not recruiting
Phases
Phase 1
Enrollment
6 participants, actual
Lead sponsor
Ipsen
Conditions
Low-grade Glioma
Interventions
Tovorafenib
First posted
2026-03-02
Last updated
2026-10-01

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of participants experiencing Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)From first dose until 30 days post-treatment
PrimaryPercentage of participants experiencing Serious Adverse Events (SAEs) and AESIsUp to 4 years from first dose, including post-treatment monitoringAn Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention.
PrimaryArea under the plasma concentration-time curve from time zero to last measurable concentration (AUC₀-t) of tovorafenib following a single doseFrom 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.
PrimaryArea under the plasma concentration-time curve from time zero extrapolated to infinity (AUC₀-inf) of tovorafenib following a single doseFrom 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.
PrimaryMaximum observed plasma concentration (Cmax) of tovorafenib following a single doseFrom 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
PrimaryTime to maximum plasma concentration following a single dose (Tmax) of tovorafenibFrom 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
PrimaryTerminal half-life (t½) of tovorafenib following a single doseFrom 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.
PrimaryArea under the plasma concentration-time curve over the dosing interval at steady-state (AUC₀-tau) of tovorafenibFrom 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
PrimaryMaximum plasma concentration at steady-state (CmaxSS) of tovorafenibFrom 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.
PrimaryMinimum plasma concentration at steady-state (CminSS) of tovorafenibFrom 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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07441707

GET https://conductscience.org/api/trials/v1/NCT07441707/registered