RET Inhibitor

A Phase 1/2 Study of the Oral RET Inhibitor Selpercatinib in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors*

NCT03899792 show modal icon
Key Inclusion Criteria
  • Pediatric patients aged 6 months to 21 years with advanced or metastatic solid or primary central nervous system (CNS) tumors and have failed standard-of-care therapies
  • Evidence of an activating RET gene alteration in the tumor and/or blood
  • Measurable or evaluable disease
  • Karnofsky (patients ≥16 years of age) or Lansky (patients <16 years of age) performance score of at least 50
  • Patients with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior to start of treatment and must not have required increasing doses of steroids within the last 7 days
  • Adequate hematologic, hepatic, and renal function
  • Able to receive study drug therapy orally or via gastric access
  • Males and females of reproductive potential must be willing to use conventional and effective birth control
Key Exclusion Criteria
  • Major surgery within 14 days prior to planned start of selpercatinib
  • Clinically significant, uncontrolled cardiac or cardiovascular disease, or history of myocardial infarction within 6 months prior to planned start of selpercatinib
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Clinically significant active malabsorption syndrome
  • Pregnant or breastfeeding
  • Uncontrolled symptomatic hyperthyroidism or hypothyroidism
  • Uncontrolled symptomatic hypercalcemia or hypocalcemia
  • For patients who will be receiving selpercatinib suspension: Known hypersensitivity to any of the components of the investigational agent or Ora-Sweet® and Ora-Plus®   
  • Prior treatment with a selective RET inhibitor(s), including investigational
This clinical trial is being conducted globally.
Selpercatinib is administered PO.
For information on trial enrollment, locations, and more, call 1-800-545-5979.