A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion
CONNECT1903
What is the goal of the study?
In this pilot study, we will assess the disease control rate [Continued Complete Response (CCR), Complete Response (CR), Partial Response (PR) and Stable Disease (SD)] in children with newly diagnosed High-Grade Glioma (HGG) with TRK fusion who receive 2 cycles of larotrectinib administered orally, twice daily, at 100 mg/m2 (or maximum of 100mg/dose) continuously on a 28-day cycle schedule. Secondary objectives include assessing the feasibility and describing the toxicities of larotrectinib as a single agent and in combination with standard chemotherapy used in children ≤ 48 months with HGG or post focal radiotherapy in children > 48 months of age. Children with HGG who have a CCR or CR after 2 cycles of therapy will continue to receive single agent larotrectinib for a total of 12 cycles. Those with PR or SD after 2 cycles of larotrectinib monotherapy will go on to receive larotrectinib either in combination with standard backbone chemotherapy (BABYPOG or HIT-SKK, investigator’s choice) or post standard radiotherapy, based on the patient’s age. Those with PD after 2 cycles will be taken off protocol therapy.
Who can participate in the study?
Please contact the study team listed below to learn more.