Entrectinib (STARTRK-NG)

Phase 1/2, open-label, dose escalation and expansion study of entrectinib (RXDX-101) in pediatrics with locally advanced or metastatic solid or primary CNS tumors and/or who have no satisfactory treatment options



In this clinical trial children and adolescents (< 18 years) will be treated with Entrectinib (RXDX-101). 

Entrectinib (also known as RXDX-101) is a potent inhibitor of TRKA, TRKB, TRKC, ROS1 (encoded by the gene ROS1), and ALK (encoded by the gene ALK). Gene rearrangements in tumor cells, leading to the expression of constitutively activated fusion tyrosine kinase receptors. Inhibiting these proteins leads to the death of the tumor cells and inhibits tumor growth. A TRKA, TRKB, TRKC, or ROS1 gene fusion must be determined using laboratory testing.

Entrectinib is taken orally over a 28-day cycle as capsules or as minitablets.

Main inclusion criteria

  • Pediatric and adolescents patients <18 years with a locally advanced or metastatic solid or primary CNS tumor harboring NTRK1/2/3 or ROS1 gene fusions as determined locally by an appropriately validated assay 
  • Karnofsky oder Lansky > 60


Hoffmann-La Roche

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