Actively Recruiting
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
Led by Massachusetts General Hospital · Updated on 2024-12-12
30
Participants Needed
6
Research Sites
148 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed follicular-derived nonanaplastic thyroid cancer that is metastatic and/or unresectable with a known RET gene fusion.
- Tumor RET fusion detection can be by tumor tissue or liquid biopsy using NGS, qPCR, or FISH.
- Participants 18 years or older must have measurable disease per RECIST v1.1; ages 12 to under 18 may have evaluable or measurable disease.
- No single tumor deposit may exceed 4.0 cm in greatest dimension.
- Participants must have radioiodine-refractory disease defined by specific criteria related to iodine uptake and progression.
- Total cumulative radioactive iodine treatment dose must not exceed 500 mCi.
- Disease must be asymptomatic or minimally symptomatic as judged by the investigator.
- Prior external beam radiotherapy allowed; disease within prior radiotherapy field must be measurable.
- No more than one prior systemic therapy for radioiodine-refractory thyroid cancer allowed; prior RET-specific kinase inhibitor therapy is not allowed.
- At least 28 days must have passed since prior radiation or major surgery and systemic therapy (excluding thyroid hormone replacement).
- Participants must be 18 years or older; ages 12 to under 18 allowed with assent and consent.
- ECOG performance status ≤1 for ages 16 and older; Lansky score ≥60 for ages 12 to under 16.
- Life expectancy greater than 12 months.
- Ability to swallow medications with no gastrointestinal abnormalities affecting absorption.
- Adequate organ and marrow function as defined by specified bloodwork within 7 days prior to treatment.
- Normal serum potassium, calcium, and magnesium levels within institutional normal range.
- HIV-positive participants on effective therapy with undetectable viral load within 6 months are eligible.
- Participants with chronic HBV must have undetectable viral load if on suppressive therapy.
- Participants with treated or cured HCV are eligible; those currently on treatment must have undetectable viral load.
- Participants with treated brain metastases must be asymptomatic with no evidence of progression on follow-up imaging.
- Participants with prior or concurrent malignancy without interference to safety or efficacy assessment are eligible.
- Participants with known or current cardiac disease must have NYHA class 2B or better.
- Women of child-bearing potential and men must use effective contraception during and 6 months after treatment.
- Women of child-bearing potential must have a negative pregnancy test within 7 days prior to treatment and not breast-feed within 2 months before and during treatment and for 1 week after last dose.
- Ability and willingness to sign informed consent.
You will not qualify if you...
- Chemotherapy, MKI, or radiotherapy within 4 weeks prior to study.
- I-131 NaI treatment within 12 months prior to study.
- Unresolved adverse events from prior anti-cancer therapy above Grade 1, except alopecia.
- Use of any other investigational agents.
- Symptomatic CNS metastasis or lesions threatening spinal cord compression.
- Clinically significant active cardiovascular disease, recent myocardial infarction within 6 months, or prolonged QTcF >470 msec.
- Uncontrolled hypertension (>160/95 mm Hg) at screening; may be re-screened after treatment.
- Active uncontrolled infections or serious ongoing illnesses preventing safe participation.
- Uncontrolled symptomatic hyperthyroidism or hypothyroidism.
- Symptomatic hypercalcemia or hypocalcemia.
- Active bleeding or significant risk for hemorrhage.
- Use of medications known to cause QTc prolongation.
- Clinically significant malabsorption or gastrointestinal conditions affecting drug absorption.
- Other uncontrolled serious illnesses interfering with study therapy.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lori J. Wirth, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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