Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)

Exclusion criteria

• . No prior systemic therapy for thyroid cancer, including RET inhibitors. Note: prior 131I is allowed.
• . Females who are pregnant or breastfeeding are excluded due to the potential risks of selpercatinib and radioactive iodine to the fetus/neonate.
• . Concurrent therapy: Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided 14 days prior to treatment to the end of the study treatment.
• . Patients with clinically significant active cardiovascular disease, Torsades de pointes, or history of myocardial infarction within 6 months prior to planned start of study treatment or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \>470 msec.
• . Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the drug.
• . Are taking a concomitant medication that is known to cause QTc prolongation.
• . Active hemorrhage or at significant risk for hemorrhage.
• . Uncontrolled hypertension (blood pressure greater than 140/90 in adults or greater than the 95% for height and gender in children). Use of anti-hypertensives to control blood pressure is permitted.