At a glance
ClinicalIndex Comparison RecordPhase 2Active· 857 enrolled
Drug / intervention
LOXO-292drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)
In Brief
A Phase 2 clinical trial evaluating LOXO-292 for Non-Small Cell Lung Cancer and 3 related conditions. Active but no longer recruiting, targeting 857 participants across 85 sites in 16 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsLoxo Oncology, Inc.
Timeline
Phase 2Active
2018201920202021202220232024202520262027
Enrollment StartMay 2017
First PostedMay 2017
Primary CompletionFeb 2025
TodayJul 2026
Study CompletionFeb 2027
First PostedMay 17, 2017
Enrollment StartMay 2, 2017
Primary CompletionFeb 14, 2025
Study CompletionFeb 1, 2027
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 9.1 years ago
Interventions
LOXO-292drug
Oral LOXO-292