Last updated on September 2017

Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE)


Brief description of study

Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.

Detailed Study Description

This is a Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3. Patients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay. LOXO-101 will be administered orally at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis. The study will analyze 8 cohorts of patients with tumors bearing NTRK fusions, including non small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer and primary CNS tumor, as well as a cohort that will enroll patients not included in the histologies listed above.

Clinical Study Identifier: NCT02576431

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Lee Rosen, MD

University of California - Los Angeles
Los Angeles, CA United States
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Shivaani Kummar, MD

Stanford University
Stanford, CA United States
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Dennis Priebat, MD

Medstar Hospital Washington
Washington, D.C., United States
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Luis Raez, MD

Memorial Hospital
Pembroke Pines, FL United States
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Jyoti Patel, MD

University of Chicago
Chicago, IL United States
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Anna Farago, MD

Massachusetts General Hospital
Boston, MA United States
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George Demetri, MD

Dana-Farber Cancer Institute
Boston, MA United States
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Mary Chamberlin, MD

Dartmouth Hitchcock Medical Center
Lebanon, NH United States
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Martin Gutierrez, MD

John Theurer Cancer Center at Hackensack
Hackensack, NJ United States
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Anne Grand'Maison, MD

Roswell Park Cancer Institute
Buffalo, NY United States
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Alex Drilon, MD

Memorial Sloan Kettering Cancer Center
New York, NY United States
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Juneko Grilley-Olson, MD

University of North Carolina (UNC)
Chapel Hill, NC United States
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Stefan Grant, MD, JD

Wake Forest Baptist Medical Center
Winston-Salem, NC United States
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Davendra Sohal, MD

Cleveland Clinic
Cleveland, OH United States
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Ashwin Sama, MD

Thomas Jefferson University
Philadelphia, PA United States
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Wafik El-Deiry, MD, PhD

Fox Chase Cancer Center
Philadelphia, PA United States
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Brian Leyland-Jones, MD

Avera Cancer Institute
Sioux Falls, SD United States
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Jordan Berlin, MD

Vanderbilt University
Nashville, TN United States
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David Hong, MD

MD Anderson Cancer Center
Houston, TX United States
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John Deeken, MD

Inova Health System
Fairfax, VA United States
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Christina Baik, MD, MPH

University of Washington - Seattle Cancer Care Alliance
Seattle, WA United States
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Patrick Ma, MD

West Virginia University
Morgantown, WV United States
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Ulrik Lassen, MD

Copenhagen University Hospital
Copenhagen, Denmark
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Antoine Italiano

Institut Bergonie
Bordeaux Cedex, France
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Ray McDermott, MD

St. Vincent's University Hospital
Dublin, Ireland
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Do-Youn Oh

Seoul National University Hospital
Seoul, Korea, Republic of
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Keunchil Park, MD, PhD

Samsung Medical Center
Seoul, Korea, Republic of
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Hyun Cheol Chung, MD

Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Nuno Sousa

Instituto Portugu s de Oncologia do Porto Francisco Gentil
Porto, Portugal
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Daniel Tan, MD

National Cancer Centre
Outram, Singapore
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Cinta Hierro Carbó

Hospital Universitario Vall d'Hebron
Barcelona, Spain
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Victor Moreno, MD

Fundacion Jimenez Diaz
Madrid, Spain
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Valentina Boni

Centro Integral Oncologico Clara Campal
Madrid, Spain
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David Propper

Barts Health NHS Trust Royal London Hospital
London, United Kingdom
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Martin Forster

University College Hospital
London, United Kingdom
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Simon Crabb

University Hospital Southampton (UHS)
Southampton, United Kingdom
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