Actively Recruiting
Restoration of Radioiodine Uptake with Selpercatinib in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer: a Phase 2 Study Performed in Collaboration with the International Thyroid Oncology Group (ITOG)
Led by Massachusetts General Hospital · Updated on 2024-12-12
30
Participants Needed
6
Research Sites
43 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
Researchers are studying the effectiveness of selpercatinib combined with standard treatments I-131 and thyrotropin alfa (rhTSH) to restore radioactive iodine uptake in people with RET fusion-positive radioiodine-refractory thyroid cancer. This Phase II clinical trial aims to see if adding selpercatinib can help these patients respond better to I-131 treatment, as current treatment options are limited for this disease type. Participants will receive selpercatinib orally twice daily for an initial 4-week treatment period. In the fourth week, they will get a therapeutic dose of I-131 NaI. If radioiodine uptake returns, participants may be offered a second 4-week course of selpercatinib with I-131 treatment. Thyrotropin alfa injections will be given according to protocol during treatment. Treatment continues as long as the disease does not worsen and side effects are manageable. During the study, participants will undergo screening, evaluations, and follow-up visits for up to 2 years after enrollment. Researchers will monitor tumor response using imaging criteria, biochemical markers, and safety assessments. The primary outcome is the objective response rate at 6 months, with secondary outcomes including restoration of iodine uptake, progression-free survival, overall survival, and treatment-related side effects. Participants will be closely followed to assess the treatment impact and safety.
CONDITIONS
Brief 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 follicular-derived nonanaplastic thyroid cancer that is metastatic and/or unresectable with a known RET gene fusion.
- Tumor RET gene fusion confirmation by CLIA-certified or equivalent laboratory using tissue or liquid biopsy.
- Participants aged 18 or older must have measurable disease; ages 12 to under 18 may have evaluable or measurable disease.
- No single tumor deposit larger than 4.0 cm.
- Must have radioiodine-refractory disease as defined by specific criteria.
- Total cumulative prior RAI treatment dose must not exceed 500 mCi.
- Disease must be asymptomatic or minimally symptomatic.
- Prior external beam radiotherapy allowed if measurable.
- No more than one prior systemic therapy for RAI-refractory thyroid cancer; prior RET-specific kinase inhibitor therapy not allowed.
- At least 28 days since prior radiation, major surgery, or systemic therapy excluding thyroid hormone replacement.
- Age 12 years or older; assent and consent required for minors.
- ECOG performance status �3 1 for ages �3 16; Lansky score �3 60 for ages 12 to under 16.
- Life expectancy greater than 12 months.
- Ability to swallow medication without gastrointestinal issues affecting absorption.
- Adequate organ and marrow function based on blood tests within 7 days before treatment.
- Normal serum potassium, calcium, and magnesium levels.
- HIV-positive participants with undetectable viral load on therapy eligible.
- Participants with controlled hepatitis B or cured hepatitis C eligible.
- Treated brain metastases allowed if asymptomatic and stable on imaging.
- Prior or concurrent malignancies allowed if not interfering with safety or efficacy.
- Cardiac function assessed with NYHA class 2B or better.
- Women and men must use effective contraception during and 6 months after treatment.
- Negative pregnancy test required for women of childbearing potential.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Chemotherapy, MKI, or radiotherapy within 4 weeks prior to study.
- I-131 treatment within 12 months prior to study.
- Unresolved toxicities from prior anticancer therapy greater than Grade 1 except alopecia.
- Use of other investigational agents.
- Symptomatic CNS metastases or lesions threatening spinal cord.
- Active significant cardiovascular disease, recent myocardial infarction, or prolonged QTcF >470 msec.
- Uncontrolled hypertension above 160/95 mm Hg at screening.
- Active uncontrolled systemic infections or serious illnesses.
- Uncontrolled symptomatic hyperthyroidism or hypothyroidism.
- Symptomatic abnormal calcium levels.
- Active bleeding or high risk for hemorrhage.
- Use of medications known to prolong QTc interval.
- Malabsorption syndromes or conditions affecting drug absorption.
- Other uncontrolled serious illnesses interfering with study therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month for up to two courses of treatment
Participants receive selpercatinib orally twice daily for approximately 4 weeks. In the fourth week, participants also receive a therapeutic dose of I-131 NaI and rhTSH injections per protocol. A second 4-week course of selpercatinib plus I-131 NaI and rhTSH may be offered if clinical benefit is demonstrated and deemed appropriate by the investigator.
Visits during treatment include medication administration and evaluations; specific visit counts are not detailed
Duration - Up to 2 years
Participants are followed for up to 2 years from the date of study registration to monitor safety, disease progression, and overall survival.
Periodic follow-up visits over 2 years
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
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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