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A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
Trial Status: closed to accrual
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.
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])
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03899792.
Locations matching your search criteria
United States
California
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Name Not Available
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Name Not Available
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In
phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The
starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160
milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or
recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of
four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype.
