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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT03899792

Run by

Eli Lilly and Company

People needed

36

Starts

2019-06-13

Expected to finish

2029-05-01

Last updated by the study team

2026-01-06

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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])

Where it is running

• Childrens Hospital of Los Angeles — Los Angeles, California, United States
• The Children's Hospital for Cancer and Blood Disorders — Aurora, Colorado, United States
• Nemours Children's Health — Orlando, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota Hospital — Minneapolis, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Texas Childrens Hospital — Houston, Texas, United States
• Seattle Children's Hospital Research Foundation — Seattle, Washington, United States
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Royal Children's Hospital — Melbourne, Victoria, Australia
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Rigshospitalet — Copenhagen, Denmark
• Gustave Roussy — Villejuif, France
• Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Lombardy, Italy
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
• Hiroshima University Hospital — Hiroshima, Japan
• Kyoto University Hospital — Kyoto, Japan
• Seoul National University Hospital — Seoul, Korea, South Korea
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.