ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias
The purpose of this study is to determine how well Larotrectinib works in treating patients with newly diagnosed TRK fusion solid tumors or relapsed or refractory TRK fusion acute leukemias. TRK fusion means that you have a change in the TRK gene in your tumor. Larotrectinib is a highly selective oral small molecule inhibitor of the TRK family of tyrosine kinases, which are encoded by the NTRK genes.
Are you Eligible? (Inclusion Criteria)
- Patient must be 30 years of age or younger at time of study entry
- Patient must have: Cohorts A & B: newly diagnosed infantile fibrosarcoma or any solid tumor, including CNS tumors but excluding high grade gliomas, with NTRK1, NTRK2, or NTRK3 fusion; or Cohort C: relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion.
- Patient must have: Cohorts A & B: measurable disease that cannot be completely resected without a predicted functional, neurologic, or significant cosmetic deficit; or Cohort C: > 5% blasts in the bone marrow. Extramedullary disease is permitted.
- Patients must also meet all other eligibility criteria as outlined in the study protocol