Selpercatinib for Solid Tumors
(LIBRETTO-001 Trial)
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does mention that you cannot take certain strong medications that affect liver enzymes (CYP3A4 inhibitors or inducers) and other prohibited medications. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug Selpercatinib for solid tumors?
Is Selpercatinib safe for humans?
Selpercatinib has been shown to have a manageable safety profile in clinical trials, with common side effects including high blood pressure, elevated liver enzymes, swelling, diarrhea, fatigue, dry mouth, abdominal pain, constipation, rash, nausea, and headache. Most side effects can be managed with dose adjustments, and only a small number of patients stopped treatment due to side effects.13456
What makes the drug Selpercatinib unique for treating solid tumors?
Selpercatinib is unique because it is a highly selective inhibitor that targets RET (rearranged during transfection) alterations, which are specific genetic changes found in some cancers. It is effective in treating RET fusion-positive cancers, including non-small cell lung cancer and thyroid cancer, and can be taken orally, making it convenient for patients.23478
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Participants receive multiple doses of LOXO-292 to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Phase 2: Dose Expansion
Participants receive the recommended phase 2 dose (RP2D) of LOXO-292 to evaluate safety, tolerability, and preliminary anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LOXO-292
LOXO-292 is already approved in United States for the following indications:
- Non-small cell lung cancer (NSCLC) with RET fusion
- Medullary thyroid cancer (MTC) with RET mutation
- Thyroid cancer with RET fusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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