IRB #

STUDY00017674

Title

A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and
Pediatric Subjects with Previously Treated NTRK Fusion
Cancers

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of the study, in phase 1, is to test the safety of a study drug called LOXO-195 (study drug) in men, women and children with previously treated NTRK Fusion cancers.

Medical Condition(s)

Previously treated NTRK fusion cancer

Eligibility Criteria

1. Recurrent or metastatic solid tumors
2. Adequate organ function
3. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the study drug as long as their cancer does not get worse and they do not develop side effects that they cannot tolerate. If your disease gets worse during the study, you may be able to remain on the study for additional treatments if the investigator thinks the study drug can continue to benefit you. After the last dose of the study drug, participants will perform a 28 day post treatment follow-up. Thereafter, they will contacted by phone every 12 weeks until the end of the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Bayer

Recruitment End

03/31/2020

Compensation Provided

No


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