A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - Any
Updated:3/30/2019
Start Date:September 30, 2015
End Date:May 31, 2021
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

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A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects With NTRK Fusion-positive Tumors

This research study is done to test how well different types of cancer respond to the drug
called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or
NTRK3). Larotrectinib is an experimental drug that blocks the actions of these NTRK genes in
cancer cells and can therefore be used to treat cancer.

The primary objective of this study is to investigate the efficacy of larotrectinib for the
treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor
kinase (NTRK) of types 1-3 in children and adults.

Secondary objectives comprise the efficacy and safety of larotrectinib in different
NTRK-tumor types.

Inclusion Criteria:

- Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion
identified through molecular assays

- Subjects must have received prior standard therapy appropriate for their tumor type
and stage of disease, or in the opinion of the investigator, would be unlikely to
tolerate or derive clinically meaningful benefit from appropriate standard of care
therapy

- Subjects must have at least one measurable lesion as defined by RECIST v1.1

Exclusion Criteria:

- Prior progression while receiving approved or investigational tyrosine kinase
inhibitors targeting TRK. Subjects who received less than 28 days of treatment and
discontinued because of intolerance or toxicity are eligible.

- Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain
metastases are eligible to participate in the study.) Subjects with primary CNS tumors
are eligible.

- Active uncontrolled systemic bacterial, viral, or fungal infection, unstable
cardiovascular disease, or other systemic disease that would limit compliance with
study procedures.

- Pregnancy or lactation.
We found this trial at
22
sites
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Sioux Falls, SD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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665 Elm Street
Buffalo, New York 14263
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Buffalo, NY
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Falls Church, Virginia 22042
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Falls Church, VA
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Guangzhou, Guangdong 51006
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Guangzhou,
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Palo Alto, California 94304
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Palo Alto, CA
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Pembroke, Florida 33140
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Pembroke, FL
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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1250 16th Street
Santa Monica, California 90404
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Santa Monica, CA
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Washington, District of Columbia 20010
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Washington,
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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