Title: A Study of Oral LOXO-292 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors (LIBRETTO-121)
Principle Investigator: Michael Cox, PharmD, MHSc, BCOP, Loxo Oncology
Description: This is an open-label, multi-center phase 1/2 study that is investigating oral administration of LOXO-292 in pediatric patients with an activating RET alteration and an advanced solid or primary central nervous system tumor. This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, patients will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 mg BID. Once the maximum tolerated dose and/or recommended phase 2 dose is identified, patients will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days. A primary outcome measure for the first phase of the trial is determining the safety of oral LOXO-292 in pediatric patients with advanced solid tumors and primary central nervous system tumors. For the phase 2 portion of the trial, primary outcome measures include determining overall response rate based on RECIST 1.1 and RANO per internal review committee.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03899792.
Status: This study is open and recruiting patients as of May 30, 2019.
This study is sponsored by Loxo Oncology, Inc.
Clinicaltrials.gov. A Study of Oral LOXO-292 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors (LIBRETTO-121). NCT03899792. https://clinicaltrials.gov/ct2/show/NCT03899792. Accessed June 24, 2019.