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Tyrosine Kinase Inhibitor

Selpercatinib for Medullary Thyroid Cancer (LIBRETTO-531 Trial)

Phase 3

Waitlist Available

Research Sponsored by Loxo Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status

A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death from any cause (estimated at up to 60 months)

Awards & highlights

LIBRETTO-531 Trial Summary

This trial is testing a new drug to see if it's more effective and safe than the current standard treatment for people with a certain type of thyroid cancer.

Who is the study for?

This trial is for adults and some minors (12+ if allowed) with advanced, inoperable or metastatic Medullary Thyroid Cancer that has a specific RET gene change. They shouldn't have had kinase inhibitor treatment before. Participants need to show disease progression, be reasonably healthy overall, able to swallow capsules, and willing to use effective contraception.Check my eligibility

What is being tested?

The study tests if Selpercatinib is safer and more effective than standard treatments (Cabozantinib or Vandetanib) for RET-mutant MTC. If the standard treatment fails, participants may switch to Selpercatinib. The goal is to compare outcomes between the new drug and existing options.See study design

What are the potential side effects?

Selpercatinib might cause liver issues, high blood pressure, bleeding problems, dry mouth or altered taste sensation; Cabozantinib can lead to diarrhea, mouth sores or hand-foot syndrome; Vandetanib may result in rash or acneiform dermatitis.

LIBRETTO-531 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor sample is large enough for further genetic testing.

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My cancer has a specific change in the RET gene.

Select...

My medullary thyroid cancer is advanced and I haven't had kinase inhibitor treatments.

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I can take care of myself and am up and about more than half of my waking hours.

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I can swallow pills.

LIBRETTO-531 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death from any cause (estimated at up to 60 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to date of death from any cause (estimated at up to 60 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death from any cause (estimated at up to 60 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) by BICR

Secondary outcome measures

Comparative Tolerability: Percentage of Time with High Side Effect Bother Based on the Functional Assessment of Cancer Therapy-Side Effects (FACT-GP5)

Duration of Response (DoR) by BICR

Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR

+4 more

LIBRETTO-531 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SelpercatinibExperimental Treatment1 Intervention

Selpercatinib given orally.

Group II: Cabozantinib or VandetanibActive Control2 Interventions

Cabozantinib or vandetanib given orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selpercatinib

2021

Completed Phase 1

~600

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,613 Previous Clinical Trials

3,200,638 Total Patients Enrolled

Loxo Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

9,578 Total Patients Enrolled

Study DirectorEli Lilly and Company

3 Previous Clinical Trials

2,710 Total Patients Enrolled

Media Library

Selpercatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04211337 — Phase 3

Medullary Thyroid Cancer Research Study Groups: Selpercatinib, Cabozantinib or Vandetanib

Medullary Thyroid Cancer Clinical Trial 2023: Selpercatinib Highlights & Side Effects. Trial Name: NCT04211337 — Phase 3

Selpercatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04211337 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the general efficacy of Selpercatinib in human trials?

"Selpercatinib was first evaluated in 2006 at Site 2. To date, there have been 124 completed clinical trials and 136 active studies. A large proportion of these are being conducted out of Portland, Oregon."

Answered by AI

How many individuals are included in this research project?

"This clinical trial needs 400 patients that fall under the specific inclusion criteria. Fortunately, there are many locations where patients can receive care including Providence Cancer Center Oncology Hematology Care in Portland, Oregon and UCSF Medical Center at Mission Bay in San Francisco, California."

Answered by AI

What are the possible risks associated with Selpercatinib?

"Selpercatinib's safety is estimated to be a 3. This assessment comes from the fact that Selpercatinib is in Phase 3 trials, which suggests that not only does some data support its efficacy, but also that multiple rounds of testing confirm its safety."

Answered by AI

Does this research stand alone or has a similar project been conducted in the past?

"Selpercatinib has been under scientific scrutiny since 2006, when the first trial was completed. This initial study was sponsored by Genzyme, which is owned by Sanofi. After the success of the first 437-person Phase 3 drug trial, Selpercatinib received official approval. At present, there are 136 ongoing clinical trials in 1534 cities and 50 countries."

Answered by AI

In how many different locations is this trial being conducted?

"So far, this trial has recruited patients from locations such as Providence Cancer Center Oncology Hematology Care in Portland, Oregon, UCSF Medical Center at Mission Bay in San Francisco, California, and London Health Science Centre - Victoria Hospital in London, Ontario. However, there are 26 other potential sites."

Answered by AI

Are there any current vacancies for participants in this research?

"This study, which was last updated on 10/18/2022, is recruiting patients according to the clinicaltrials.gov website."

Answered by AI

What medical condition is Selpercatinib commonly used to treat?

"Selpercatinib is most often used as a cancer treatment, but it can also be effective for patients with adrenal medulla, high risk patients, and medullary carcinoma of thyroid."

Answered by AI

Recent research and studies

Current Opinion in Endocrinology, Diabetes & ObesityJournal

Medullary Thyroid Carcinoma

Jaber, Tania, Ramona Dadu, and Mimi I. Hu. 2021. “Medullary Thyroid Carcinoma”. Current Opinion in Endocrinology, Diabetes & Obesity. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/med.0000000000000662.

Current Opinion in Endocrinology, Diabetes & ObesityJournal

Medullary Thyroid Carcinoma

retJournal

LIBRETTO-531: A Phase III Study of Selpercatinib in Multikinase Inhibitor-naïve <i>ret</i>-mutant Medullary Thyroid Cancer

Wirth, Lori J, Marcia S Brose, Rossella Elisei, Jaume Capdevila, Ana O Hoff, Mimi I Hu, Makoto Tahara, et al.. 2022. “LIBRETTO-531: A Phase III Study of Selpercatinib in Multikinase Inhibitor-naïve ret-mutant Medullary Thyroid Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2022-0657.

clinicaltrials.govStudy

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer