Bayer: ON-TRK for Solid Tumors

ON-TRK: PrOspective Non-interventional study in patients
with locally advanced or metastatic TRK fusion cancer treated with larotrectinib

The purpose of this study is to assess the safety and tolerability of of Larotrectinib in patients with locally advanced or metastatic solid tumor harboring NTRK gene fusion for whom a decision to treat with larotrectinib has been made before enrollment. TRK fusion cancer is rare but presents as a variety of solid tumors. Larotrectinib is a highly selective TRK inhibitor that, in a pooled analysis of patients in phase ½ clinical trials, demonstrated an effective and sustained response in the majority of patients with TRK fusion cancer.

Larotrectinib is approved with a relatively small number of patients enrolled to one of three early phase trials. The results indicated clinical effectiveness for Larotrectinib in patients with TRK fusion cancer; but the available safety data are relatively limited. This post-approval study will generate additional safety data in a larger population.
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