ON-TRK: larotrectinib observational study (v1.0)
Research type
Research Study
Full title
ON-TRK: Prospective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib
IRAS ID
286828
Contact name
Hellen McGoey
Contact email
Sponsor organisation
Bayer Plc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EUPAS32136, EU PAS register number
Duration of Study in the UK
7 years, 8 months, 30 days
Research summary
Tropomyosin receptor kinase (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 1/2 clinical trials, demonstrated an effective and sustained response in the majority of patients with TRK fusion cancer.
Because of the limited number of patients treated with larotrectinib, information relating to its safety profile in a broader population and over extended time periods is lacking. Therefore, there is a need for data in a larger patient population, and for real-world data on larotrectinib treatment.
This study will describe the safety and effectiveness of larotrectinib under real-world treatment conditions and provide information about the management of patients with locally advanced or metastatic TRK fusion cancer in standard clinical practice.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0364
Date of REC Opinion
2 Feb 2021
REC opinion
Further Information Favourable Opinion