About this study
This is a Phase II study of larotrectinib, a type of drug that works by blocking cell signal proteins that are thought to be important for tumors to grow. In a Phase II study, the goal is to find out what effects, good and/or bad, a drug or combination of drugs has on people with a type of cancer.
We are using larotrectinib in this study because it has been shown to block the growth of cancer cells with TRK fusions in children and adults who have TRK fusion cancers that have not gone away or have come back after standard therapy. In children and adults with TRK fusion cancers, larotrectinib has caused tumors to shrink in most but not all patients. This study will evaluate what the effects of larotrectinib are if given at the time cancer is first diagnosed instead of standard therapy. We do not know if it will work against your cancer.
Larotrectinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children and adults with TRK fusion cancers that have spread after standard therapy, are not able to be surgically removed after standard therapy, or for whom there is no standard therapy available. Using larotrectinib to treat patients with newly diagnosed TRK fusion cancers, as is being done in this study, is still experimental.
Eligibility overview
- 21 years old or younger
- Newly diagnosed infantile fibrosarcoma or solid tumor with NTRK1, NTRK2 or NTRK3 fusion OR
- Relapsed/refractory acute leukemia with NTRK1, NTRK2 or NTRK3 fusion