At a glance
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A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors
In Brief
A Phase 2 clinical trial evaluating Larotrectinib (Vitrakvi, BAY2757556) for Solid Tumors Harboring NTRK Fusion. Active but no longer recruiting, targeting 154 participants across 45 sites in 21 countries.
Detailed Summary
The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.
Study Details
Timeline
Interventions
BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.