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NCT03157128 · ClinicalTrials.gov registry record · 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)

A Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 1
Development phase
857
Enrollment target
20
Study locations

NCT03157128 is a Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 857 participants, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT03157128, a Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
857 participants
Enrollment target
20
Study locations

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

1,341 total trials

What the Registry Record Tells You About NCT03157128

The ClinicalTrials.gov registry entry for NCT03157128 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 857 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (30% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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.

NCT03157128 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Maryland.

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.

What interventions are being tested in trial NCT03157128?

The interventions under investigation include: LOXO-292 (DRUG).

Who is sponsoring clinical trial NCT03157128?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.