Breast Cancer Clinical Trial
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.
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
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])
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There are 27 Locations for this study
Los Angeles California, 90027, United States More Info
Palo Alto California, 94304, United States More Info
Aurora Colorado, 80045, United States More Info
Orlando Florida, 32827, United States More Info
+91 407567 4000
Boston Massachusetts, 02215, United States More Info
Minneapolis Minnesota, 55454, United States More Info
New York New York, 10065, United States More Info
Cincinnati Ohio, 45229, United States More Info
Philadelphia Pennsylvania, 19104, United States More Info
Memphis Tennessee, 38105, United States More Info
Dallas Texas, 75390, United States More Info
Houston Texas, 77025, United States More Info
Seattle Washington, 98105, United States More Info
Sydney New South Wales, 2031, Australia More Info
Parkville Victoria, 3052, Australia More Info
+ 61 3 93459180
Toronto Ontario, M5G 1, Canada More Info
Copenhagen Hovedstaden, 2100, Denmark More Info
Villejuif Cedex , 94805, France More Info
Heidelberg Baden-Württemberg, 69120, Germany More Info
+49 6221 56-36926
Milan Lombardia, 20133, Italy More Info
Sapporo Hokkaido, 060-8, Japan More Info
Chuo-ku Tokyo, 104-0, Japan More Info
Hiroshima , 734-8, Japan More Info
Kyoto , 606-8, Japan More Info
Seoul Korea, 03080, Korea, Republic of More Info
London Greater London, NW1 2, United Kingdom More Info
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