Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE) (NCT06458036) | Clinical Trial Compass
RecruitingPhase 2
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
United States13 participantsStarted 2024-07-29
Plain-language summary
Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.
Who can participate
Age range2 Years – 25 Years
SexALL
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Inclusion criteria
✓. Age 2-25 years, inclusive
✓. Histologic diagnosis of a differentiated thyroid cancer, status post thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of care) for metastatic disease in the neck in the opinion of the treating investigator
✓. Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment):
✓. Identification of an activating RET gene alteration (fusion or mutation). The RET alteration result should be generated from a laboratory with specific certifications (depending on country requirement) that clearly denotes the presence of a RET alteration without known kinase domain resistance mutation
✓. Lansky/Karnofsky performance status \>50%
✓. Adequate Organ Function
✓. Patient must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements)
✓. Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 6 months following the last dose of study drug. Selpercatinib could impair fertility in males and females. Advise women not to breastfeed during treatment with selpercatinib and for 1 week following the final dose
Exclusion criteria
✕. No prior systemic therapy for thyroid cancer, including RET inhibitors. Note: prior 131I is allowed.
What they're measuring
1
Number of patients with complete overall, pulmonary, structural, and biochemical response.
Timeframe: 18 months
2
Number of patients who survive without progression of disease after 5 years following protocol treatment.
Timeframe: 5 years
3
Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.
Timeframe: 6 months
4
The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5.
. 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.