Solid Tumor and Leukemia Treatment with Larotrectinib – Phase II

ADVL1823: Larotrectinib for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are investigating the potential of larotrectinib for treatment of certain cancers in infants, children and young adults. Specifically researchers will evaluate larotrectinib used in treatment of solid tumors with a mutation called a TRK fusion or leukemia that has come back or been resistant to standard therapy. Larotrectinib is a type of drug that works by blocking cell signal proteins that are thought to be important for tumors to grow.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling pediatric patients who have a newly diagnosed tumor that has not been previously treated or leukemia that is refractory or recurrent.
Males and Females: Up to 30 years of age


Participants will take larotrectinib twice daily as a capsule or liquid in 28-day cycles and may continue to receive it for up to 2 years, barring serious side effects or worsening of the cancer. If necessary, leukemia patients may receive additional drugs through spinal infusion at certain intervals. Throughout the treatment period, participants’ cancer will be evaluated at intervals defined in the protocol. Participants will need maintain and submit monthly medication journals for the research team. Participants will be followed for up to 3 years following end of treatment.
Visits: Approximately monthly through the 2-year dosing period, however the actual number of visits will vary by cohort and individual patient condition.
Duration: Up to 2 years for treatment with participants followed for another 3 years

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1823)

Primary Investigator

Andrew Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact:
Sharon Dibridge, Clinical Research Coordinator