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

NCT02122913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

  • Solid Tumors Harboring NTRK Fusion

Interventions

DRUG

Larotrectinib (Vitrakvi, BAY2757556)

BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-04
Primary Completion
2017-02-01
Completion
2021-04-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02122913 on ClinicalTrials.gov