No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 25
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
13 (estimated)
Sponsor
Children's Hospital of Philadelphia · Other
Who this trial is looking for
This trial is looking for young patients aged 2 to 25 who have been diagnosed with certain types of thyroid cancer and have had surgery. Participants will receive a treatment called selpercatinib before traditional radioactive iodine therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 2 and 25 years old.
I have been diagnosed with differentiated thyroid cancer.
I have had surgery for my thyroid cancer.
I have certain types of lung nodules on a recent chest CT scan.
I have a specific genetic change called a RET alteration.
I have good overall health with a performance status over 50%.
I have normal levels of certain minerals like potassium and calcium.
I agree to use effective birth control during and after the study.
You may not be able to join if
I have previously received systemic therapy for thyroid cancer.
I am pregnant or breastfeeding.
I am currently taking strong medications that affect liver enzymes.
I have significant heart problems or a recent heart attack.
I have severe issues with absorbing medication.
I have active bleeding or am at risk for it.
I have uncontrolled high blood pressure.
I am taking medications that can prolong heart rhythm.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 i…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Age 2-25 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. A…
Inclusion Criteria:
1. Age 2-25 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):
A. multiple (\> 10) noncalcified solid pulmonary nodules visible on CT and/or B. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
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
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 creatinine based on age/gender.
C. Adequate Liver Function
* 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
Exclusion Criteria:
1. No prior systemic therapy for thyroid cancer, including RET inhibitors. Note: prior 131I is allowed.
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.
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