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

Completed · Phase 1

Conditions studied: Solid Tumors Harboring NTRK Fusion

In brief

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.

Key facts

Study ID

NCT02122913

Run by

Bayer

People needed

75

Starts

2014-05-04

Expected to finish

2021-04-09

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists
• Proof of a malignancy harboring a NTRK fusion
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 and a life expectancy of at least 3 months
• Adequate hematologic, hepatic, and renal function

You may not qualify if…

• Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible
• Clinically significant active cardiovascular disease or history of myocardial infarction
• Active uncontrolled systemic bacterial, viral, or fungal infection
• Current treatment with a strong CYP3A4 inhibitor or inducer
• Pregnancy or lactation

Where it is running

• UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora, Colorado, United States
• Mass General Cancer Center — Boston, Massachusetts, United States
• UH Seidman Cancer Center — Cleveland, Ohio, United States
• OHSU Hospital - Neurology — Portland, Oregon, United States
• Hospital of the University of Pennsylvania - Radiology — Philadelphia, Pennsylvania, United States
• UPMC Mercy - Oncology — Pittsburgh, Pennsylvania, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center - Texas Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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