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 Cancer*
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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
*
This clinical trial is being conducted globally.
†
Selpercatinib 160 mg is administered PO BID.
‡
Cabozantinib 140 mg is administered PO QD.
§
Vandetanib 300 mg is administered PO QD.
