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

• Status: Recruiting
• Trial end date: 2024-03-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loxo Oncology, Inc.
• Collaborator: Eli Lilly and Company

Criteria

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])