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ACTIVE NOT RECRUITING Phase 1

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

NCT03157128 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG LOXO-292

Study Locations (20)

California

  • City of Hope National Medical Center — Duarte
  • UCLA Medical Center — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Kaiser Permanente — Oakland
  • Irvine Medical Center — Orange
  • University of California - San Diego — San Diego
  • UCSF Medical Center at Mission Bay — San Francisco
  • Kaiser Permanente Medical Center — Walnut Creek

Florida

  • Mayo Clinic in Florida — Jacksonville
  • Memorial Hospital Pembroke — Pembroke

Maryland

  • University of Maryland Medical Center — Baltimore
  • Johns Hopkins University — Baltimore

Massachusetts

  • Massachusetts General Hospital — Boston
  • Dana-Farber Cancer Institute — Boston

Arizona

  • Mayo Clinic of Scottsdale — Scottsdale

Colorado

  • Sarah Cannon Research Institute at HealthOne — Denver

Connecticut

  • Yale Cancer Center — New Haven

Georgia

  • Emory University — Atlanta

Trial Details

FieldValue
Enrollment Target 857 participants
Start Date 2017-05-02
Est. Completion 2027-02
Phase Phase 1

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03157128

The ClinicalTrials.gov registry entry for NCT03157128 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 857 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which LOXO-292 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03157128 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03157128 about?

NCT03157128 is a clinical study titled "A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)". 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...

What is the current status of trial NCT03157128?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 857 participants. The study started on 2017-05-02. Estimated completion is 2027-02.

What conditions does trial NCT03157128 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colon Cancer, Medullary Thyroid Cancer, Any Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03157128?

The interventions under investigation include: LOXO-292 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03157128?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03157128 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial