Selpercatinib for Solid Tumors

(LIBRETTO-001 Trial)

Recruiting at108 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral drug called selpercatinib in patients with advanced cancers that have specific gene changes. The drug aims to block a gene that helps cancer grow, potentially slowing or stopping the disease.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for people with advanced solid tumors, RET fusion-positive solid tumors, or medullary thyroid cancer who have tried standard treatments without success or can't tolerate them. They must have a life expectancy of at least 3 months and good organ function. People with certain genetic alterations may join only after Sponsor approval. Those who've had recent major surgery, other cancer therapies, or untreated brain metastases are excluded.

Inclusion Criteria

My lung cancer is in an early stage, operable, and has not been treated yet.

My cancer does not initially need a RET gene alteration, but will require it after initial treatment.

You have a disease that can be measured by specific guidelines for your type of tumor.

Exclusion Criteria

I have not had major surgery in the last 2 weeks.

I am not taking strong drugs that affect liver enzymes or forbidden medications.

I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.

Treatment Details

Interventions

• LOXO-292 (Tyrosine Kinase Inhibitor)

Trial Overview The study tests Selpercatinib (LOXO-292), an oral medication targeting specific genetic changes in tumors. It's given to participants with various types of advanced cancers to assess its safety and how well it works against these cancers.

Participant Groups

Group I: LOXO-292 Experimental Treatment 1 Intervention

Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology