A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
857actual
Sites
85
Countries
Australia, Canada, Denmark +13
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 | 2017-05-02 | actual | When the study began enrolling |
| Primary completion | 2025-02-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2017-05-17 | actual | When this record first appeared on the registry |
| Results posted | 2026-04-16 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-Small Cell Lung Cancer
- Medullary Thyroid Cancer
- Colon Cancer
- Any Solid Tumor
Intervention
- Drug: LOXO-292 — also filed as Selpercatinib, LY3527723
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Maximum Tolerated Dose (MTD)
measured Cycle 1 (cycle length = 28 days)
Phase 1: Recommended Phase 2 Dose (RP2D)
measured Cycle 1 (cycle length = 28 days)
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
measured Approximately for up to 7 years 8 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-08-15 · 1.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-12-19 · 632 KB · SAP_001.pdf
Publications
- PMID 39983053 — linked by the registry
- PMID 39471424 — linked by the registry
- PMID 39094065 — linked by the registry
- PMID 39085487 — linked by the registry
- PMID 38661071 — linked by the registry
- PMID 37934000 — linked by the registry
- PMID 37265412 — linked by the registry
- PMID 36657661 — linked by the registry
- PMID 36122315 — linked by the registry
- PMID 36108661 — linked by the registry
- PMID 35930972 — linked by the registry
- PMID 34088726 — linked by the registry
- PMID 32846061 — linked by the registry
- PMID 32846060 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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