A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
- Conditions
- Advanced RET-Altered Solid or Primary Central Nervous System Tumors
- Registration Number
- JPRN-jRCT2080225127
- Lead Sponsor
- Eli Lilly and Company / ICCC :Medpace Japan KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 100
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]).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>For Phase 1 [ Time Frame: During the first 28-day cycle of LOXO-292 treatment ]<br>-To determine the safety of oral LOXO-292 in pediatric participants with advanced solid tumors: Dose limiting toxicities (DLTs)<br>-To determine the safety of oral LOXO-292 in pediatric participants with primary central nervous system (CNS) tumors: Dose limiting toxicities (DLTs) <br>For Phase 2 [ Time Frame: Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months) ]<br>-Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Independent Review Committee (IRC) <br>-ORR Based on Response Assessment in Neuro-Oncology (RANO) per IRC
- Secondary Outcome Measures
Name Time Method