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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Loxo Oncology, Inc.
Study ID
NCT04211337
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Medullary Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selpercatinib — DRUG
    Administered orally
  • Cabozantinib — DRUG
    Administered orally
  • Vandetanib — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Feb 11, 2020
Status verified
Mar 2026
Primary completion
May 22, 2023
Completion
Nov 30, 2027

Study Design

Enrollment
291 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selpercatinib - Treatment A (TRT A)
    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).
  • Active Comparator: Cabozantinib or Vandetanib - Treatment B (TRT B)
    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

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause, Whichever Occurs First, Up to 39 Months ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
City of Hope National Medical CenterDuarteCalifornia91010-0269-
UCLA Hematology/Oncology - Westwood (Building 100)Los AngelesCalifornia90095-
University of California Davis (UC Davis) Comprehensive Cancer CenterSacramentoCalifornia95817-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
Emory UniversityAtlantaGeorgia30322-
University of Chicago Medical CenterChicagoIllinois60637-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10017-
University of Cincinnati Medical CenterCincinnatiOhio45219-
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19114-
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Hospitals and ClinicsMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope National Medical Center· Duarte, CAUCLA Hematology/Oncology - Westwood (Building 100)· Los Angeles, CAUniversity of California Davis (UC Davis) Comprehensive Cancer Center· Sacramento, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAEmory University· Atlanta, GA

Related Studies