Larotrectinib (LOXO-101)

Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Sold or Primary Central Nervous System Tumors

Recruiting

Summary

In this study, children and adolescents aged 1 to 21 years with an advanced or metastatic solid tumor - a primary tumor of the central nervous system or IFS (infantile fibrosarcoma) - are treated with LOXO-101 (Larotrectinib). Larotrectinib specifically inhibits tropomyosin receptor kinases (TRK), a group of signaling proteins that play an important role in cellular communication and tumor growth. The study therefore treats tumors whose genetic information has changed in this area (NTRK fusion) and where the tumor has recurred or progressed after standard therapy. Larotrectinib is taken orally over a 28-day cycle.

Main inclusion criteria

  • Children and adolescents between 0 and 21 years with a locally advanced or metastatic IF with a positive ETS gene variation 6 (ETV6) detected by FISH or by molecular analysis
  • Children and adolescents between 0 and 21 years with a locally advanced solid tumors or primary central nervous system tumors with NTRK gene fusion
  • At least one measurable lesion according to RECIST or RANO
  • Karnofsky oder Lansky > 50

Sponsor

Bayer

Diese Webseite verwendet Cookies. Durch die Nutzung der Webseite stimmen Sie der Verwendung von Cookies zu. Datenschutzinformationen