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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
RET Inhibitor
Selpercatinib
Phase
3
Not Enrolling
A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Physician’s Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor-Naïve, RET-Mutant Medullary Thyroid Cancera
Related Resources:
Molecule Overview Trial Enrollment
NCT04211337 show modal icon
Key Inclusion Criteria
  • Patients ≥12 years of age
  • Unresectable, locally advanced and/or metastatic medullary thyroid cancer (MTC) and no prior treatment with kinase inhibitors for advanced/metastatic disease
  • Radiographic progressive, evaluable disease at screening
  • A defined RET gene alteration identified in a tumor, germline DNA, or blood sample
    • Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate organ function
  • Patients with reproductive potential must use a highly effective contraceptive method for the duration of treatment and for 4 months after
  • Able to swallow capsules
Key Exclusion Criteria
  • An additional validated oncogenic driver in MTC, if known, that could cause resistance to selpercatinib treatment
  • Symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months
  • History of torsades de pointes
  • Prolongation of the QTc interval of >470 ms using Fridericia’s formula on more than one electrocardiogram during screening
    • Participants intended to receive vandetanib if QTc is >450 ms
  • Active bacterial, viral, or fungal infection, or serious uncontrolled and ongoing illness
  • Active or at significant risk for hemorrhage
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ, or malignancy diagnosed ≥2 years previously and not currently active
    • Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible
a
This clinical trial is being conducted globally.
b
Administered at 160 orally BID.
c
Administered at 140 mg orally QD.
d
Administered at 300 mg orally QD.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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or visit www.clinicaltrials.gov for more information on this trial