RET Inhibitor
Selpercatinib
Phase
2
Enrolling
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*
Related Resources:
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.
