Condition: Low-grade Glioma · Sponsor: Ipsen
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 determine if they can take part in the study, requiring at least one visit to the study centre. 2. Treatment period (up to 24 months): All eligible participants will receive tovorafenib. This requires five visits for the first 2 months (Cycle 1 and Cycle 2) followed by one visit every month (at the start of each treatment cycle). Participants will receive the first oral dose of tovorafenib on Day 1 of Cycle 1 at the study clinic. After Day 1, participants will need to take tovorafenib once weekly on Day 8, Day 15 and Day 22. Participants will be required to come to the study clinic in person at least five times for Cycle 1 and Cycle 2. In addition, participants will have one remote visit (telephone call) during Cycle 1. After Cycle 2, only one in-person clinic visit is required at the start of each treatment cycle. A participant will stop treatment if their disease gets worse, if…
This description comes directly from the study's public registry record.
Ipsen Clinical Study Enquiries · See e-mail · clinical.trials@ipsen.com
Always discuss trial participation with your own doctor first.
| Kanagawa Children's Medical Center | Kanagawa, Japan | Not Yet Recruiting |
| Hyogo Prefectural Kobe Children's Hospital | Kobe, Japan | Recruiting |
| Kyoto University Hospital | Kyoto, Japan | Recruiting |
| Osaka City General Hospital | Osaka, Japan | Recruiting |
| National Cancer Center Hospital | Tokyo, Japan | Recruiting |
| National Center for Child Health and Development | Tokyo, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07441707