A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04211337|
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : May 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Medullary Thyroid Cancer||Drug: Selpercatinib Drug: Cabozantinib Drug: Vandetanib||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||May 20, 2024|
|Estimated Study Completion Date :||November 13, 2026|
Selpercatinib given orally.
Active Comparator: Cabozantinib or Vandetanib
Cabozantinib or vandetanib given orally.
- Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR) [ Time Frame: Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause (Estimated at up to 30 Months) ]TFFS by BICR
- Progression Free Survival (PFS) by BICR [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 30 Months) ]PFS by BICR
- Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR [ Time Frame: Baseline through Disease Progression or Death (Estimated at up to 30 Months) ]ORR: Percentage of Participants with CR or PR by BICR
- Duration of Response (DoR) by BICR [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 30 Months) ]DoR by BICR
- Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated at up to 60 Months) ]OS
- PFS2 by Investigator [ Time Frame: Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 48 Months) ]PFS2 by Investigator
- Comparative Tolerability: Percentage of Time with High Side Effect Bother Based on the Functional Assessment of Cancer Therapy-Side Effects (FACT-GP5) [ Time Frame: Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause (30 months) ]FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer. The single FACT-G item, GP5, "I am bothered by side effects of treatment," is a summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of adverse events in clinical trials. It uses a 5-point rating scale (0="not at all" and 4=equals "very much"). Higher GP5 scores indicates more bother from side effects
- The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement) [ Time Frame: Baseline ]The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211337
|Contact: There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.firstname.lastname@example.org|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM||Eli Lilly and Company|