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New treatment option for Differentiated Thyroid Cancer
Official title Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
ClinicalTrials.gov ID: NCT06458036
What this study is testing
What is Selpercatinib Monotherapy?
Selpercatinib Monotherapy is an investigational medicine, being studied as a potential treatment for differentiated thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 25
You may be able to join if
- 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...
- Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment): A...
- Identification of an activating RET gene alteration (fusion or mutation). The RET alteration result should be generated from a laboratory with...
- Lansky/Karnofsky performance status \>50%
You likely can't join if
- 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...
- Patients with clinically significant active cardiovascular disease, Torsades de pointes, or history of myocardial infarction within 6 months prior to...
- 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.
See the full eligibility 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...
- Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment): A. multiple (\> 10) noncalcified solid pulmonary nodules visible on CT...
- 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...
- Lansky/Karnofsky performance status \>50%
- Adequate Organ Function A. Bone Marrow Function:
- Peripheral absolute neutrophil count (ANC) ≥1500/µL
- Platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
- Hemoglobin ≥ 9.0 g/dL at baseline (may receive Red Blood Cell transfusions). B. Adequate Renal Function: Creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL/min/1.73 m2 or a maximum serum...
- Bilirubin (sum of conjugated + unconjugated) \< / = 1.5 x upper limit of normal (ULN) for age. Except participants with a documented history of Gilbert syndrome who must have a total bilirubin level of \<3.0X ULN
- Alanine aminotransferase (ALT) \<2.5X ULN OR \<5x ULN if the liver has tumor involvement. For the purpose of this study, the ULN for ALT is 45 U/L.
- Serum albumin ≥ 2 g/dL
- 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...
- Women of childbearing potential must have a negative pregnancy test (serum or urine, consistent with local regulations) documented within 24 hours prior to treatment with study drug and at least monthly while on study...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Memphis, Tennessee, United States; Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.