A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
36actual
Sites
26
Countries
Australia, Canada, Denmark +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-06-13 | actual | When the study began enrolling |
| Primary completion | 2024-11-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2019-04-02 | actual | When this record first appeared on the registry |
| Results posted | 2026-01-06 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Medullary Thyroid Cancer
- Infantile Myofibromatosis
- Infantile Fibrosarcoma
- Papillary Thyroid Cancer
- Soft Tissue Sarcoma
Intervention
- Drug: Selpercatinib — also filed as LOXO-292, LY3527723
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
measured Cycle 1 (28 Day Cycle)
Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study
measured Date of first dose to disease progression or death (Up to 62.4 Months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-02-21 · 7.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-08-20 · 930 KB · SAP_001.pdf
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