NCT02576431

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

A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors 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-tumor types.

Conditions

• Solid Tumors Harboring NTRK Fusion

Interventions

Type	Name	Description
DRUG	BAY2757556 (Larotrectinib, Vitrakvi)	Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.

Timeline

• Start date: 2015-09-30
• Primary completion: 2025-09-29
• Completion: 2025-09-29
• First posted: 2015-10-15
• Last updated: 2025-11-12

Locations

98 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, India, Ireland, Italy, Japan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study