A Phase I/II Study of LOXO-292 in Pediatric Patients with Recurrent or Persistent RET-Driven Solid Tumors, including Tumors of the Thyroid and Brain

Full Title

LOXO-RET-18036 A Phase 1/ 2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Purpose

Some cancers have been found to grow because they carry a mutation in a gene called RET. The investigational drug LOXO-292 specifically blocks the activity of the RET gene, and researchers think this will slow or stop the growth of cancer cells.

The purpose of this study is to find the highest dose of LOXO-292 that can be given safely in children with recurrent inoperable or metastatic solid tumors, including thyroid cancer and tumors in the brain and spinal cord, which contain an alteration or mutation in the RET gene. LOXO-292 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’ tumors must contain a RET gene mutation or alteration.
  • Patients must be at least 6 months of age and no older than 21 years.
  • Patients must have an inoperable or metastatic tumor, including those in the thyroid, brain, or spinal cord, that came back or continued to grow despite prior treatment.
  • Patients should recover from the serious side effects of previous treatments before entering the study.

For more information about this study and to inquire about eligibility, please contact Jeanette Enriquez at 212-639-3694.

Protocol

19-197

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators