Larotrectinib in adult patients with solid tumours: a multi-centre, open-label, phase I dose-escalation study.

ABSTRACT:

Background

NTRK1, NTRK2 and NTRK3 gene fusions (NTRK gene fusions) occur in a range of adult cancers. Larotrectinib is a potent and highly selective ATP-competitive inhibitor of TRK kinases and has demonstrated activity in patients with tumours harbouring NTRK gene fusions.

Patients and methods

This multi-centre, phase I dose escalation study enrolled adults with metastatic solid tumours, regardless of NTRK gene fusion status. Key inclusion criteria included evaluable and/or measurable disease, Eastern Cooperative Oncology Group performance status 0-2, and adequate organ function. Larotrectinib was administered orally once or twice daily, on a continuous 28-day schedule, in increasing dose levels according to a standard 3 + 3 dose escalation scheme. The primary end point was

SUBMITTER: Hong DS 

PROVIDER: S-EPMC6386027 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature