A Study of Oral LOXO-292 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors

Why are we doing this research?

To determine the safety of oral LOXO-292 in pediatric patients with advanced solid tumors: Dose limiting toxicities (DLTs) [ Time Frame: During the first 28-day cycle of LOXO-292 treatment ]

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

Who can participate?

Inclusion Criteria:

  • Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
  • Evidence of an activating RET gene alteration in the tumor and/ or blood
  • Measurable or non-measurable disease
  • Karnofsky (patients 16 years and older) or Lansky (patients younger than 16) performance score of at least 50.
  • Patient with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days.
  • Adequate hematologic, hepatic and renal function.
  • Ability to receive study drug therapy orally or via gastric access
  • Willingness of men and women of reproductive potential to observe conventional and effective birth control

Exclusion Criteria:

  • Major surgery within 4 weeks prior to planned start of LOXO-292.
  • Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292.
  • Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
  • Clinically significant active malabsorption syndrome.
  • Pregnancy or lactation
  • Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the patient required a modification to current thyroid medication in the 7 days before start of LOXO-292).
  • Uncontrolled symptomatic hypercalcemia or hypocalcemia.
  • Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
  • Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for patients who will receive LOXO-292 suspension.
  • Current treatment with proton pump inhibitors.
  • Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]).

Ages

  • 6 Months to 21 Years  

Conditions

  • Brain Spinal Tumors Medulloblastoma New Diagnosis
  • Adult - Brain Spinal Tumors Medulloblastoma New Diagnosis
  • Brain Spinal Tumors Medulloblastoma Relapse
  • Adult - Brain Spinal Tumors Medulloblastoma Relapse
  • Brain Spinal Tumor Low Grade Glioma Relapse
  • Adult - Brain Spinal Tumor Low Grade Glioma Relapse
  • Brain Spinal Tumor DIPG New Diagnosis
  • Adult - Brain Spinal Tumor DIPG New Diagnosis
  • Brain Spinal Tumor DIPG Relapse
  • Adult - Brain Spinal Tumor DIPG Relapse
  • Brain and Spinal Tumor Ependymoma Relapse
  • Brain and Spinal Tumor Ependymoma New Diagnosis
  • Adult - Brain and Spinal Tumor Ependymoma New Diagnosis
  • Adult - Brain and Spinal Tumor Ependymoma Relapse
  • Brain Spinal Neurofibromatosis Sarcoma MPNST New Diagnosis
  • Brain Spinal Neurofibromatosis Sarcoma MPNST Relapse
  • Adult - Brain Spinal Neurofibromatosis Sarcoma MPNST Relapse
  • Adult - Brain Spinal Neurofibromatosis Sarcoma MPNST New Diagnosis
  • Brain Spinal Neurofibromatosis Plexiform Neurofibroma
  • Adult - Brain Spinal Neurofibromatosis Plexiform Neurofibroma
  • Brain Spinal Neurofibromatosis OPG
  • Adult - Brain Spinal Neurofibromatosis OPG
  • Sarcoma Osteosarcoma Relapse
  • Adult - Sarcoma Osteosarcoma Relapse
  • Sarcoma Ewing New Diagnosis
  • Adult - Sarcoma Ewing New Diagnosis
  • Sarcoma Ewing Relapse
  • Adult - Sarcoma Ewing Relapse
  • Sarcoma Rhabdomyosarcoma New Diagnosis
  • Sarcoma Rhabdomyosarcoma Relapse
  • Adult - Sarcoma Rhabdomyosarcoma Relapse
  • Adult - Sarcoma Rhabdomyosarcoma New Diagnosis
  • Neuroblastoma New Diagnosis
  • Neuroblastoma Relapse - Refractory
  • Adult - Neuroblastoma New Diagnosis
  • Adult - Neuroblastoma Relapse - Refractory
  • Adult - Liver New Diagnosis
  • Adult - Liver Relapse - Refractory
  • Liver New Diagnosis
  • Liver Relapse - Refractory
  • Kidney Relapse - Refractory
  • Adult - Kidney Relapse - Refractory

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org