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

The purpose of this study is to evaluate safety and the way the body absorbs, distributes and gets rid of the study drug tovorafenib in the body in Japanese children, adolescents and young adults with specific brain tumours. This includes how the drug is absorbed, distributed and eliminated from the body (called pharmacokinetics). The study will also test how well the drug works to shrink brain tumours. In this study, all participants will receive tovorafenib orally once weekly. There will be four periods in this study: 1. Screening period (up to 4 weeks): Participants will be evaluated to

Trial Details

NCT ID
NCT07441707
Phase
PHASE1
Sponsor
Ipsen
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Tovorafenib
Locations (sample)
  • Kanagawa, Japan|37.58333,139.91667
  • Kobe, Japan|34.6913,135.183
  • Kyoto, Japan|35.02107,135.75385
  • Osaka, Japan|34.69379,135.50107
  • Tokyo, Japan|35.6895,139.69171

Key Eligibility Criteria

  • Participants must be 6 months to 25 years of age, inclusive, with at least two generations of Japanese ancestry at the time of signing the informed…
  • Participants must have relapsed or progressive low-grade glioma with a documented known activating BRAF alteration, including BRAF V600 mutations a…
  • Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.
  • Participants must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.

For full eligibility, visit ClinicalTrials.gov.

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