The purpose of this study is to describe, under real-world conditions, the safety and effectiveness of larotrectinib in patients with locally advanced or metastatic TRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment.
ON-TRK
Prospective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib
Solid tumors
All genders
No minimum age
Recruiting now
Overview
Principal Investigator: Paul Mathew, MD
Contact Us
Sarah Sexton
Study details
Inclusion Criteria
- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion.
- Life expectancy of at least 3 months based on clinical judgement
- Decision to treat with larotrectinib made by the treating physician prior to study enrollment
Exclusion Criteria
- Any contraindications as listed in the local approved product information
- Pregnancy
- Participation in an investigational program with interventions outside of routine clinical practice
Study Requirements
This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional study. Patients with locally advanced or metastatic TRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment will be eligible for the study.
This study is designed to describe safety and tolerability in patients treated with larotrectinib. It will also collect data to describe the effectiveness of larotrectinib in TRK fusion cancer, patterns of treatment, and the influence of baseline characteristics and treatment history.
Data will be collected from up to 300 patients with NTRK gene fusion globally over a total study period of 5 years (8 years for pediatric cohort), including 36 months’ enrollment and a minimum of 24 months’ observation time from study entry for all cohorts but pediatric cohort.