A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: LOXO-292

Eligibility


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 (participants 16 years and older) or Lansky (participants younger than 16)
   performance score of at least 50

   - Participant 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 two 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 participant
   required a modification to current thyroid medication in the 7 days before start of
   LOXO-292)

   - Uncontrolled symptomatic hypercalcemia or hypocalcemia

   - Known hypersensitivity to any of the components of the investigational agent, LOXO-292
   or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension

   - Prior treatment with a selective RET inhibitor(s) (including investigational selective
   RET inhibitor[s])

Ages Eligible for Study

6 Months - 21 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs Peds Hem/Onc CRAs
I'm interested

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.