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NCT03157128 · ClinicalTrials.gov record · last posted 2026-04-16

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

Study acronym: LIBRETTO-001
StatusActive, Not Recruiting
PhasePhase 1/2
Started2017-05-02
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from the ClinicalTrials.gov record
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Amendment record 114 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 114 times since 2017-05-15; most recent amendment 2026-03-27. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-11-08
Status change Recruiting→Active, Not Recruitingv107
Trial Details
NCT Number NCT03157128
Lead Sponsor Eli Lilly and Company
Collaborators: Loxo Oncology, Inc.
Conditions Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor
Enrollment 857 participants
Start Date 2017-05-02
Primary Completion 2025-02-14 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-04-16