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Spots Global Cancer Trial Database for A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT02122913

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Colorado, Aurora, Colorado, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Oregon Health and Science University, Portland, Oregon, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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