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Larotrectinib, phase I in adults
Multicentre, phase I dose escalation study enrolled
adults
with metastatic solid tumours, regardless of NTRK gene fusion status.
Larotrectinib-related adverse events were predominantly grade 1; none were grade 4 or 5. The most common grade 3
larotrectinib-related adverse event was anaemia 6%.
A dose of 100 mg twice-daily was recommended for phase II.
In patients with evaluable TRK fusion cancer, the objective response rate by independent review was 100% (eight of eight
patients). Median duration of response was not reached.
Eight (12%) of 67 evaluable patients overall had an objective response by investigator assessment.
Larotrectinib had limited activity in tumours with NTRK mutations or amplifications
Hong D. Ann Oncol 2019