RECRUITING

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

Conditions

Differentiated Thyroid Cancer Pediatric Cancer Cancer Cancer, Thyroid Thyroid Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Selpercatinib to Enhance RAI Avidity in Children, Adolescents, and Young Adults With Newly Diagnosed Differentiated Thyroid Cancers Harboring RET Fusions

Quick Facts

Study Start:2024-07-29

Study Completion:2031-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06458036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 2-21 years, inclusive 2. 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 3. Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment): 4. 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 5. Lansky/Karnofsky performance status \>50% 6. Adequate Organ 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). * 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 7. Patient must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements) 8. 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 9. 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 treatment	1. No prior systemic therapy for thyroid cancer, including RET inhibitors or 131I. 2. Females who are pregnant or breastfeeding are excluded due to the potential risks of selpercatinib and radioactive iodine to the fetus/neonate. 3. 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. 4. 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. 5. Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the drug. 6. Are taking a concomitant medication that is known to cause QTc prolongation. 7. Active hemorrhage or at significant risk for hemorrhage. 8. 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.

Inclusion Criteria

Exclusion Criteria

1. Age 2-21 years, inclusive
2. 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
3. Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment):
4. 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
5. Lansky/Karnofsky performance status \>50%
6. Adequate Organ 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).
* 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
7. Patient must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements)
8. 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
9. 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 treatment

1. No prior systemic therapy for thyroid cancer, including RET inhibitors or 131I.
2. Females who are pregnant or breastfeeding are excluded due to the potential risks of selpercatinib and radioactive iodine to the fetus/neonate.
3. 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.
4. 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.
5. Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the drug.
6. Are taking a concomitant medication that is known to cause QTc prolongation.
7. Active hemorrhage or at significant risk for hemorrhage.
8. 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.

Contacts and Locations

Study Contact

Shelby Brizzolara-Dove

CONTACT

267-426-9293

23DT022@chop.edu

James Robinson

CONTACT

215-590-2053

robinsonj9@chop.edu

Principal Investigator

Theodore Laetsch, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Theodore Laetsch, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-29

Study Completion Date2031-11-01

Study Record Updates

Study Start Date2024-07-29

Study Completion Date2031-11-01

Terms related to this study

Keywords Provided by Researchers

Thyroid Cancer

Additional Relevant MeSH Terms

Differentiated Thyroid Cancer
Pediatric Cancer
Cancer
Cancer, Thyroid