Selpercatinib for Medullary Thyroid Cancer
(LIBRETTO-531 Trial)

Recruiting in Palo Alto (17 mi)

+268 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Loxo Oncology, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

My tumor sample is large enough for further genetic testing.

My cancer has a specific change in the RET gene.

My cancer has grown according to recent scans, not just in bones.

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Exclusion Criteria

I am currently experiencing significant bleeding or at high risk for serious bleeding.

I don't have serious heart issues or recent heart attacks, and my ECG results are within safe limits.

I do not have any uncontrolled infections or serious ongoing illnesses.

See 3 more

Treatment Details

Interventions

Cabozantinib (Tyrosine Kinase Inhibitor)
Selpercatinib (Tyrosine Kinase Inhibitor)
Vandetanib (Tyrosine Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Selpercatinib - Treatment A (TRT A)Experimental Treatment1 Intervention

160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).

Group II: Cabozantinib or Vandetanib - Treatment B (TRT B)Active Control2 Interventions

140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD