A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumours

Official Title

A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumours

Summary:

This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

Trial Description

Primary Outcome:

• Best overall response rate by IRC

Secondary Outcome:

• Best overall response rate by investigator
• Duration of response (DOR) by IRC
• Duration of response (DOR) by investigator
• Clinical benefit rate (CBR)
• Progression-free survival (PFS) after Larotrectinib
• Overall survival time
• Progression-free survival (PFS) after past cancer therapy
• Number of subjects with adverse events
• Number of subjects with serious adverse events
• Number of subjects with treatment-related adverse events
• Severity of adverse events
• Severity of serious adverse events
• Severity of treatment-related adverse events
• Duration of adverse events
• Duration of serious adverse events
• Duration of treatment-related adverse events
• Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administration
• Severity of safety-relevant changes in clinical parameters or vital signs after drug administration

The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumours harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults. Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumour types.

View this trial on ClinicalTrials.gov