{"commentary":{"count":16,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":7,"youtube":6,"podcast":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04211337\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"LIBRETTO-531","nct_id":"NCT04211337","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=libretto-531-nct04211337. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"LIBRETTO-531","arms":[{"description":"160 milligrams Selpercatinib administered orally (PO) twice daily (BID).\n\nAdolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).","label":"Selpercatinib - Treatment A (TRT A)","type":"EXPERIMENTAL"},{"description":"140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.\n\nCabozantinib Adolescent Dose: 40 mg/m2.\n\nVandetanib Adolescent Dose:\n\n* 0.7 - \\<0.9 - 100 mg every other day (QOD)\n* 0.9 - \\<1.2 - 100 mg QD\n* 1.2 - \\<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg\n* ≥1.6 - 200 QD","label":"Cabozantinib or Vandetanib - Treatment B (TRT B)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Eli Lilly and Company"],"completion_date":{"date":"2027-11","type":"ESTIMATED"},"conditions":["Medullary Thyroid Cancer"],"enrollment":{"count":291,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Selpercatinib","type":"DRUG"},{"name":"Cabozantinib","type":"DRUG"},{"name":"Vandetanib","type":"DRUG"}],"last_update":"2026-03-19","lead_sponsor":"Loxo Oncology, Inc.","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)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-05-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)","timeFrame":"Baseline to Progressive Disease or Death from Any Cause, Whichever Occurs First, Up to 39 Months"}],"references":[{"citation":"Payakachat N, Gilligan AM, Altman D, Maeda P, Choi J, Bourke S, Speck RM, Spies E, Kopeckova K, Elisei R, Wadsley J, Krajewska J. Assessing side-effect bother, burden, and tolerability: A qualitative study exploring the content validity of the Functional Assessment of Cancer Therapy - Item GP5. J Geriatr Oncol. 2025 Sep;16(7):102304. doi: 10.1016/j.jgo.2025.102304. Epub 2025 Jul 4.","pmid":"40617171","type":"DERIVED"},{"citation":"Regnault A, Bunod L, Loubert A, Brose MS, Hess LM, Maeda P, Lin Y, Speck RM, Gilligan AM, Payakachat N. Assessing tolerability with the Functional Assessment of Cancer Therapy item GP5: psychometric evidence from LIBRETTO-531, a phase 3 trial of selpercatinib in medullary thyroid cancer. J Patient Rep Outcomes. 2024 Dec 19;8(1):149. doi: 10.1186/s41687-024-00823-8.","pmid":"39694978","type":"DERIVED"},{"citation":"Hadoux J, Elisei R, Brose MS, Hoff AO, Robinson BG, Gao M, Jarzab B, Isaev P, Kopeckova K, Wadsley J, Fuhrer D, Keam B, Bardet S, Sherman EJ, Tahara M, Hu MI, Singh R, Lin Y, Soldatenkova V, Wright J, Lin B, Maeda P, Capdevila J, Wirth LJ; LIBRETTO-531 Trial Investigators. Phase 3 Trial of Selpercatinib in Advanced RET-Mutant Medullary Thyroid Cancer. N Engl J Med. 2023 Nov 16;389(20):1851-1861. doi: 10.1056/NEJMoa2309719. Epub 2023 Oct 21.","pmid":"37870969","type":"DERIVED"},{"citation":"Wirth LJ, Brose MS, Elisei R, Capdevila J, Hoff AO, Hu MI, Tahara M, Robinson B, Gao M, Xia M, Maeda P, Sherman E. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naive RET-mutant medullary thyroid cancer. Future Oncol. 2022 Sep;18(28):3143-3150. doi: 10.2217/fon-2022-0657. Epub 2022 Aug 15.","pmid":"35969032","type":"DERIVED"},{"citation":"Jaber T, Dadu R, Hu MI. Medullary thyroid carcinoma. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):540-546. doi: 10.1097/MED.0000000000000662.","pmid":"34292174","type":"DERIVED"}],"start_date":{"date":"2020-02-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer","url":"https://clinicaltrials.gov/study/NCT04211337"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/libretto-531-nct04211337"}