NCT02122913

A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is done to test the safety of the drug larotrectinib in adult cancer patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also investigates how the drug is absorbed and processed in the human body. This is the first study to test larotrectinib in humans with cancer, for whom no other effective therapy exists.

Detailed description

The trial will be conducted in 2 parts: an initial dose escalation phase of larotrectinib in subjects with advanced solid tumors will be followed by an expansion phase in subjects with solid tumors having a NTRK fusion. The objectives of the study are to determine the safety, pharmacokinetic profile, recommended dose and efficacy of orally administered larotrectinib in patients with NTRK fusions.

Conditions

• Solid Tumors Harboring NTRK Fusion

Interventions

Type	Name	Description
DRUG	Larotrectinib (Vitrakvi, BAY2757556)	BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.

Timeline

• Start date: 2014-05-04
• Primary completion: 2017-02-01
• Completion: 2021-04-09
• First posted: 2014-04-25
• Last updated: 2026-02-05

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study