Last updated on July 2019

A Study to Test the Safety of the Investigational Drug Loxo-195 in Children and Adults That May Treat Cancer


Brief description of study

This research study is done to test the safety of the new drug Loxo-195 in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test Loxo-195 in humans with cancer, for whom no other effective therapy exists.

Detailed Study Description

The trial will be conducted in 2 parts: dose escalation (Phase I ) and dose expansion (Phase 2) .

The primary objective of Phase 1 is to establish the recommended dose of Loxo-195 to treat neurotrophic tyrosine kinase (NTRK) fusion cancers in patients a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase 1 are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors.

The primary objective of Phase 2 is to assess the overall response rate in NTRK fusion cancer patients as determined by an independent review committee (IRC). Secondary objectives of Phase 2 comprise the safety and efficacy of Loxo-195 at the recommended dose.

Clinical Study Identifier: NCT03215511

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Stanford Cancer Center

Stanford, CA United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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MD Anderson Cancer Center

Houston, TX United States
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Seattle Children's

Seattle, WA United States
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Righospitalet

Copenhagen, Denmark
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Gustave Roussy

Villejuif cedex, France
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Huntsman Cancer Institute

Salt Lake City, UT United States
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Stanford Cancer Center

Palo Alto, CA United States
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University of Michigan

Ann Arbor, MI United States
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Eastern Regional Medical Center

Philadelphia, PA United States
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University of Utah

Salt Lake City, UT United States
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Seattle Children's Hospital

Seattle, WA United States
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Westmead Hospital

Randwick, Australia
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Austin Health

Heidelberg, Australia
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Finsen Centre

Copenhagen, Denmark
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Recruitment Status: Open


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