NCT03215511

A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer

A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.

Detailed description

The primary objective is to determine the recommended dose for further study of oral selitrectinib with previously treated neurotrophic tyrosine kinase (NTRK) cancers in 2 patient groups: a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase I are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors.

Conditions

• Solid Tumors Harboring NTRK Fusion

Interventions

Type	Name	Description
DRUG	Selitrectinib (BAY2731954)	Selitrectinib is administered as capsules or liquid formulation.

Timeline

• Start date: 2017-07-03
• Primary completion: 2022-04-11
• Completion: 2023-01-30
• First posted: 2017-07-12
• Last updated: 2024-10-30

Locations

29 sites across 10 countries: United States, Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Singapore, Spain

Regulatory

• FDA-regulated drug study