An Expanded Access Study of LOXO-292 in Patients with Advanced or Metastatic Solid Tumors with RET Mutations

Print

Full Title

A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)

Purpose

LOXO-292 is an investigational drug designed to inhibit cancer growth by blocking a protein called RET. This study is making LOXO-292 available to patients with advanced or metastatic solid tumors who are not eligible to participate in other studies assessing this drug and who have few or no other treatment options. Patients’ cancers must contain fusions or mutations in the RET gene. LOXO-292 is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced or metastatic solid tumor that has a RET fusion or mutation and cannot be treated successfully with another therapy.
  • Patients must be ineligible for other clinical trials of LOXO-292.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Drilon at 646-888-4206.

Protocol

19-257

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators