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New treatment option for Thyroid Cancer
Official title Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
ClinicalTrials.gov ID: NCT05668962
What this study is testing
What is Selpercatinib?
Selpercatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for thyroid cancer.
Also referred to as Retevmo.
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
- This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131 NaI) uptake and allow for I-131 treatment in people with RET fusion-positive radioiodine-refractory thyroid cancer. This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 month
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Participants must have histologically- or cytologically-confirmed follicular-derived nonanaplastic thyroid cancer that is metastatic and/or...
- Tumor tissue or liquid biopsy-based next-generation sequencing (NGS), quantitative polymerase chain reaction (qPCR), and fluorescence in situ...
- Participants ≥ 18 years of age must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. \-- Participants 12 to \...
- Participants should have no single tumor deposit exceeding 4.0 cm in the greatest dimension.
- Participants must have RAI-refractory disease, as defined by:
You likely can't join if
- Participants who have had chemotherapy, MKI or radiotherapy within 4 weeks.
- Participants who have had I-131 NaI treatment within 12 months.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the...
- Participants who are receiving any other investigational agents.
- Participants with symptomatic CNS metastasis or lesions threatening for spinal cord compression are not eligible.
- Participants with clinically significant active cardiovascular disease or history of Torsades de pointes, history of myocardial infarction within 6...
See the full eligibility criteria
Who can join
- Participants must have histologically- or cytologically-confirmed follicular-derived nonanaplastic thyroid cancer that is metastatic and/or unresectable AND harbors a known oncogenic RET gene fusion, performed in a...
- Tumor tissue or liquid biopsy-based next-generation sequencing (NGS), quantitative polymerase chain reaction (qPCR), and fluorescence in situ hybridization (FISH) for RET gene fusion detection will be permitted.
- Participants ≥ 18 years of age must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. \-- Participants 12 to \ 1 cm) or measurable disease per RECIST v1.1.
- Participants should have no single tumor deposit exceeding 4.0 cm in the greatest dimension.
- Participants must have RAI-refractory disease, as defined by:
- The malignant tissue does not concentrate RAI on a whole body scan following radioiodine administration
- The tumor tissue has lost the ability to concentrate RAI on a whole body scan following radioiodine administration after previous evidence of uptake at any earlier timepoint,
- RAI is taken up in some but not all tumor deposits on a whole body scan following radioiodine administration and/or
- There is progressive disease per RECIST v1.1 despite RAI uptake on a whole body scan following radioiodine administration and/or
- For patients 12 to \<18 years of age, there is persistent anatomically visible tumor on cross sectional imaging following prior therapeutic radioiodine administration
- Participants may have received no more than a total cumulative RAI dose for treatment (not including RAI given for diagnostic purposes only) of 500 mCi (18.5 GBq).
- Participants must have asymptomatic or minimally symptomatic disease, as judged by the treating investigator. For example, patients with bone metastasis associated with mild pain not requiring narcotics for pain...
- Prior external beam radiotherapy is allowed. For participants with disease limited to a prior radiotherapy field, this must be considered measurable per RECIST v1.1.
- Participants may have had no more than one prior systemic therapy for RAI-refractory thyroid cancer, including lenvatinib, sorafenib, or other MKIs. This also includes chemotherapy and/or targeted therapy administered...
- At least 28 days must have passed since any prior radiation or major surgery. At least 28 days must have passed since any prior systemic therapy for thyroid cancer, excluding thyroid hormone replacement.
- Participants must be ≥18 years of age. Patients as young as 12 years of age will be allowed if permitted by local regulatory authorities and institutional review boards. \-- All patients of 12 to \< 18 years of age will...
- Participants ≥ 16 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Participants 12 to \<16 years of age must have a Lansky Performance Score of ≥ 60.
- Participants must have a life expectancy greater than 12 months.
- Participants must have the ability to swallow medications and have no gastrointestinal abnormality that may alter medication absorption.
- Participants must have adequate organ and marrow function as defined below. Bloodwork must be collected within 7 days prior to Cycle 1 Day 1:
- leukocytes ≥3,000/mcL
- absolute neutrophil count (ANC) ≥1,500/mcL
- platelets ≥100,000/mcL
- hemoglobin ≥9 g/dL
- total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) OR \<3.0 x institutional ULN for participants with Gilbert syndrome
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN OR ≤5 × institutional ULN if the liver has tumor involvement
- creatinine ≤ institutional ULN OR creatinine clearance ≥30 mL/min
- Participants must have serum potassium, calcium and magnesium levels within institutional range of normal (may be receiving supplements). Bloodwork must be collected within 7 days prior to Cycle 1 Day 1.
- Known human immunodeficiency virus (HIV)-infected participants on effective anti- retroviral therapy with an undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with treated brain metastases are eligible if the patient is asymptomatic AND follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Selpercatinib may impair fertility in men and women. The effects of selpercatinib on the developing human fetus are unknown. For this reason and because selpercatinib as well as other therapeutic agents used in this...
- WOCBP must have a negative pregnancy test (serum or urine) within 7 days prior to initiating study treatment, and not be breast-feeding within two months prior to study entry, during treatment, and for ≥1 week after the...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Participants who have had chemotherapy, MKI or radiotherapy within 4 weeks.
- Participants who have had I-131 NaI treatment within 12 months.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
- Participants who are receiving any other investigational agents.
- Participants with symptomatic CNS metastasis or lesions threatening for spinal cord compression are not eligible.
- Participants with clinically significant active cardiovascular disease or history of Torsades de pointes, history of myocardial infarction within 6 months prior to planned start of study treatment, or prolongation of...
- Participants with uncontrolled hypertension at screening, as defined by \>160/95 mm Hg.
- Participants with uncontrolled hypertension at screening may be re-screened after appropriate medical therapy for hypertension.
- Participants with an active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment, a clinical diagnosis or...
- Participants with uncontrolled symptomatic hyperthyroidism or hypothyroidism.
- Participants with symptomatic hypercalcemia or hypocalcemia.
- Participants with active hemorrhage or at significant risk for hemorrhage.
- Participants who are taking a concomitant medication that is known to cause QTc prolongation ).
- Participants with clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the drug.
- Participants with other uncontrolled serous intercurrent illness that would interfere with the ability to proceed with study therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, 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 study runs about 1 month per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, 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.