For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.
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*
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
- Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
- 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®
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.