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.
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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.
Reference
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.
