IRB #

STUDY00018164

Title

A PHASE 1/2 STUDY OF ORAL LOXO-292 IN PATIENTS WITH ADVANCED SOLID TUMORS, INCLUDING RET FUSION-POSITIVE SOLID TUMORS, MEDULLARY THYROID CANCER AND OTHER TUMORS WITH RET ACTIVATION (LIBRETTO-001)

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this research study is to test the safety of different doses of the LOXO-292, and to find out what effects it may cause in men and women with advanced solid tumors. The study includes subjects with RET-fusion solid tumors, medullary thyroid cancer (MTC), and other tumors with RET activity.

Medical Condition(s)

RET-fusion solid tumors
Medullary thyroid cancer (MTC),
Other tumors with RET activity.

Eligibility Criteria

1. Men and women 18 years or older
2. Men and women with advanced solid tumors, including RET-fusion medullary thyroid cancer (MTC), and other tumors with increased RET activity.
3. Adequate organ function
4. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug for as long as:
- You and your investigator feels that you are tolerating the study drug.
- The investigator feels it is in your best interest to continue receiving study drug
- You follow directions of the investigator
- And if you are female and able to become pregnant, you do not become pregnant.

After you finish treatment, you will be asked to return to clinic 28 days after your last dose of the study drug for a safety assessment visit. Afterwards your investigator will continue to follow your condition every 3 months for up to 2 years.

Minors Included

No

Contact

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

Sponsor

Loxo Oncology Inc.

Recruitment End

05/31/2020

Compensation Provided

No


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