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

Trial ID or NCT#

NCT03899792

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Eligibility Criteria

Ages Eligible for Study: 6 Months to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Peds Hem/Onc CRAs Peds Hem/Onc CRAs

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