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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 31, 2014
End Date:December 31, 2019

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A Phase 1 Study of the Oral TRK Inhibitor LOXO-101 in Adult Patients With Solid Tumors

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
8
sites
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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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Aurora, Colorado 80045
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Aurora, CO
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Cleveland, OH
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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mi
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Philadelphia, PA
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