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Protocol No. UW19094

Principal Investigator Bruce, Justine

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

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)

Objective We want to find out if a drug called LY3527723 (selpercatinib) is a better treatment for medullary thyroid cancer than cabozantinib or vandetanib. Selpercatinib is investigational. This means that the US Food and Drug Administration (FDA) has not approved selpercatinib for the treatment of medullary thyroid cancer, and selpercatinib can only be given in a research study. Cabozantinib and vandetanib are both approved by the FDA for the treatment of medullary thyroid cancer

Treatment You will be assigned one of three arms by chance you will know which medication you are on:
  • Selpercatinib 160 mg orally twice a day OR
  • Cabozantinib 140 mg orally once a day OR
  • Vandetanib 300 mg orally once a day
    If you are not assigned to take selpercatinib, your doctor decides whether to give you cabozantinib or vandetanib
    If your disease progresses while on cabozantinib or vandetanib, you may be allowed to transition to selpercatinib

  • Description Phase 3 Trial Comparing Selpercatinib to Cabozantinib or Vandetanib in Patients with RET-Mutant Medullary Thyroid Cancer

    Key Eligibility
  • Histologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease. Prior systemic or radiation therapy in the adjuvant setting may be allowed with discussion and approval by the Lilly CRS/CRP
  • Radiographic progressive, measurable disease per RECIST 1.1
  • A RET gene alteration identified in a tumor, germline DNA or blood sample, as defined by the protocol
  • ECOG Performance status 0-2
  • Ability to swallow capsules and comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation
  • Must have discontinued from previous treatments as defined by the protocol and fully recovered
  • Adequate organ function as defined by the protocol
  • Must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements)
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Can not be pregnant or breastfeeding
    EXCLUSION
  • An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS gene mutations and ALK gene fusions
  • Symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients are eligible if neurologically stable and without increase in steroid dose for 14 days prior to the first dose of study treatment and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS)
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of study treatment, history of Torsades de pointes, or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) greater than 470 msec on more than one ECG during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the investigator’s discretion if clinically safe to do so. Patients who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is greater than 450msec
  • Patients with implanted pacemakers may enter study without meeting QTc criteria due to nonevaluable measurement
  • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment, a clinical diagnosis or symptoms of interstitial lung disease, or other serious medical conditions which in the medical judgment of the investigator would prevent the patient from safely participating (screening for chronic conditions is not required)
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
  • Uncontrolled symptomatic hyperthyroidism or hypothyroidism, or symptomatic hypercalcemia or hypocalcemia
  • Prior systemic treatment with kinase inhibitor(s)
  • Taking a concomitant medication that is known to cause QTc prolongation as defined by the protocol

  • Applicable Disease Sites Thyroid

    Status Open

    Participating Institutions UW Hospital and Clinics