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.