A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
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.
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. Cycle length will be 28 days.
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])