Study on Selpercatinib Before Radioactive Iodine in Patients with RET Fusion Thyroid Cancer (RAISE)

Sponsor: Children's Hospital of Philadelphia

Sponsor score: 60

ClinicalTrials ID:NCT06458036

Provider View

This clinical trial is exploring whether using the drug selpercatinib before radioactive iodine therapy can help treat patients with a specific type of thyroid cancer that has a RET gene fusion.

Patient Parameters

Program Overview

Papillary thyroid cancer is the most common type of thyroid cancer. Typically, after surgery, patients with advanced thyroid cancer receive radioactive iodine (RAI) therapy. However, less than 25% of patients with cancer spread to the lungs fully respond to RAI, and it can cause lung damage and increase the risk of other cancers. This study aims to test the safety and effectiveness of using selpercatinib before RAI therapy in patients with RET fusion thyroid cancer.

Description

This study is open to patients and will not randomly assign treatments. It will test how well the combination of selpercatinib followed by radioactive iodine (131I) works for patients with RET fusion thyroid cancer. The main goal is to see how the lungs respond to this treatment combination after 18 months. Patients will take selpercatinib for six months before receiving 131I therapy. This study does not require special approval from the FDA for new drugs.

Eligibility Criteria

Inclusion Criteria

  • Age between 2 and 21 years.
  • Diagnosed with differentiated thyroid cancer and have had surgery and local treatment for cancer spread in the neck.
  • Have lung nodules visible on a CT scan that meet specific criteria.
  • Have a RET gene alteration confirmed by a certified lab.
  • Have a performance status score above 50%.
  • Have adequate organ function, including:
    • Bone marrow: Neutrophil count ≥1500/µL, Platelet count ≥100,000/µL, Hemoglobin ≥9.0 g/dL.
    • Kidneys: Creatinine clearance or GFR ≥70 mL/min/1.73 m2.
    • Liver: Bilirubin ≤1.5x ULN, ALT ≤2.5x ULN (or ≤5x ULN if liver has tumor), Serum albumin ≥2 g/dL.
  • Normal levels of potassium, calcium, and magnesium.
  • Agree to use effective birth control during and for 6 months after treatment.
  • Women must have a negative pregnancy test before and during treatment.

Exclusion Criteria

  • No previous systemic therapy for thyroid cancer, including RET inhibitors or radioactive iodine.
  • Pregnant or breastfeeding women cannot participate due to potential risks.
  • Cannot be taking strong CYP3A4 inducers or inhibitors during the study.
  • Cannot have significant heart disease or a history of heart attack within 6 months.
  • Cannot have conditions affecting drug absorption in the gut.
  • Cannot be taking medications that prolong the QT interval.
  • Cannot have active bleeding or be at high risk for bleeding.
  • Cannot have uncontrolled high blood pressure.

Locations

FACILITYZIPCITYSTATE
Children's Hospital of Philadelphia19104PhiladelphiaPennsylvania

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