Clinical Trials for Medullary Thyroid Cancer
There are currently 4 ongoing clinical trials for medullary thyroid cancer, evaluating targeted therapies including cabozantinib, selpercatinib, and vandetanib across multiple European countries. These studies focus on patients with advanced or metastatic disease, particularly those with RET gene alterations, and range from dose comparison studies to head-to-head treatment comparisons.
Clinical trial locations
- Belgium
- Croatia
- Czechia
- Denmark
- France
- Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer
- Study on the Effects of Selpercatinib in Children with Advanced RET-Altered Solid Tumors or Primary Central Nervous System Tumors
- Study on the Effects of Selpercatinib in Patients Aged 12 and Older with Advanced Solid Tumors with RET Gene Alteration
- Germany
- Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer
- Study on the Effects of Selpercatinib in Children with Advanced RET-Altered Solid Tumors or Primary Central Nervous System Tumors
- Study on the Effects of Selpercatinib in Patients Aged 12 and Older with Advanced Solid Tumors with RET Gene Alteration
- Greece
- Hungary
- Italy
- Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer
- Study on the Effects of Selpercatinib in Children with Advanced RET-Altered Solid Tumors or Primary Central Nervous System Tumors
- Study on the Effects of Selpercatinib in Patients Aged 12 and Older with Advanced Solid Tumors with RET Gene Alteration
- Netherlands
- Poland
- Romania
- Spain
- Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer
- Study on the Effects of Selpercatinib in Children with Advanced RET-Altered Solid Tumors or Primary Central Nervous System Tumors
- Study on the Effects of Selpercatinib in Patients Aged 12 and Older with Advanced Solid Tumors with RET Gene Alteration
Comparison of two doses of cabozantinib (60 mg vs 140 mg) in patients with progressive metastatic medullary thyroid cancer
This study is examining whether a lower dose of cabozantinib can be as effective as the standard higher dose for treating metastatic disease that is getting worse. The medication, available as tablets or capsules under the brand names CABOMETYX and COMETRIQ, works by blocking specific proteins that help cancer cells grow and spread.
Who can join: Participants must be at least 18 years old with confirmed disease that has spread to other parts of the body and shows evidence of progression within the past four months. Candidates should have measurable tumors visible on scans and adequate blood cell counts, liver function, and kidney function. They must have recovered from side effects of any previous treatments and be able to perform daily activities with minimal assistance. Effective birth control is required for sexually active participants during the study and for four months afterward.
Who cannot join: People who have previously been treated with cabozantinib, have untreated or unstable brain metastases, experienced significant bleeding in the past six months, or have uncontrolled high blood pressure are not eligible. The study also excludes those with recent major surgery, serious heart conditions, active infections requiring treatment, severe liver or kidney problems, pregnancy or breastfeeding, or difficulty swallowing oral medications.
Study focus: The trial compares the effectiveness of 60 mg versus 140 mg daily doses of cabozantinib in a blinded manner, meaning neither patients nor doctors know which dose is being given. Researchers will track how well the treatment works by measuring whether the cancer stops growing or shrinks, and how long patients live without disease progression.
Treatment being tested: Cabozantinib is an oral medication that targets multiple receptor tyrosine kinases involved in tumor growth, including RET, MET, and VEGFR2. It aims to slow or stop cancer progression by blocking the signaling pathways that promote cancer cell growth and survival.
Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer
This trial is comparing three different targeted therapies for patients with advanced disease caused by changes in the RET gene. The study evaluates whether the newer medication selpercatinib offers advantages over two currently available treatments.
Who can join: Participants must have disease that cannot be surgically removed or has spread to other parts of the body, with imaging evidence showing cancer growth in the last 14 months. Confirmation of a RET gene mutation is required. Candidates should be in fair to good general health without other serious medical conditions and must commit to using highly effective contraception during the study.
Who cannot join: People who have already been treated with kinase inhibitors, those without a confirmed RET mutation, patients not experiencing progressive cancer, or those whose disease is not considered advanced cannot participate.
Study focus: The trial randomly assigns participants to receive either selpercatinib or a physician’s choice of cabozantinib or vandetanib. Regular monitoring through imaging studies and blood tests evaluates how well each treatment controls cancer progression and measures progression-free survival.
Treatments being tested: Selpercatinib is an investigational medication that specifically targets and inhibits the RET protein involved in cancer growth. Cabozantinib blocks multiple pathways cancer cells use to grow and spread. Vandetanib interferes with cancer cells’ ability to grow and divide by targeting RET, VEGFR, and EGFR pathways.
Study on the Effects of Selpercatinib in Children with Advanced RET-Altered Solid Tumors or Primary Central Nervous System Tumors
This pediatric study examines the safety and effectiveness of selpercatinib in young patients with advanced tumors that have specific RET gene alterations. The trial includes both solid tumors and those located in the brain or spinal cord.
Who can join: Young patients aged 12 to 21 years with solid or central nervous system tumors that have returned, worsened, or not responded to available treatments are eligible. Participants must have adequate blood health, liver function, pancreas function, and kidney function. They need to be able to swallow capsules or take medication through a tube and must have a tumor tissue sample available. Those with brain tumors or metastases must have stable neurological symptoms. Performance scores measuring ability to perform daily activities must meet minimum thresholds, and effective birth control is required for those who can have children.
Who cannot join: Patients without advanced RET-altered solid tumors or primary central nervous system tumors, those outside the specified age range, individuals unable to take selpercatinib due to allergies, those with interfering medical conditions, participants in other trials, pregnant or breastfeeding patients, those not recovered from previous treatments, and individuals with certain heart conditions are excluded.
Study focus: The trial has two phases. Phase 1 determines the safety of selpercatinib and identifies appropriate dosing. Phase 2 evaluates how well tumors respond to treatment by measuring changes in tumor size. Regular monitoring tracks treatment response and side effects throughout the study, which is expected to continue until late 2024.
Treatment being tested: Selpercatinib is an oral RET inhibitor that targets and blocks the RET protein contributing to tumor growth. The medication is available in tablet or oral solution form and is being studied to determine if it is safe and effective for pediatric patients with RET gene alterations.
Study on the Effects of Selpercatinib in Patients Aged 12 and Older with Advanced Solid Tumors with RET Gene Alteration
This study investigates selpercatinib in patients aged 12 and older with advanced solid tumors harboring RET gene alterations. The research includes various tumor types where the RET gene is active, including specific types of thyroid cancer.
Who can join: Patients must be at least 12 years old with locally advanced or metastatic solid tumors showing evidence of RET gene alteration in the tumor or blood. For Phase 1, participants need to have tried standard treatments without success, be unable to tolerate them, or have no standard treatment options available. They must have adequate blood health, liver function, and kidney function, be able to swallow capsules and attend clinic visits, and agree to use effective birth control. Phase 1 requires a life expectancy of at least three months, an archived tumor tissue sample, and a performance status score meeting minimum thresholds. Phase 2 participants must have measurable tumors that can be tracked for size changes.
Who cannot join: Patients younger than 12 years old, those without locally advanced or metastatic solid tumors, and individuals without evidence of a RET gene alteration in their tumor or blood are not eligible.
Study focus: The trial is divided into two phases. Phase 1 aims to find the best dose of selpercatinib that can be used safely. Phase 2 evaluates how effective the medication is in shrinking tumors. Patients take the medication orally as a capsule, with some potentially receiving a placebo for comparison. Regular check-ups monitor health and treatment effects throughout the study, which continues until 2028.
Treatment being tested: Selpercatinib is an oral targeted therapy that selectively inhibits the RET kinase involved in cancer cell growth and spread. It is being studied for its effectiveness in treating advanced solid tumors with RET gene alterations, with ongoing research to determine optimal dosage and therapeutic potential.
Summary
The four ongoing clinical trials for medullary thyroid cancer demonstrate a strong focus on targeted therapies for patients with RET gene alterations. Three of the four trials investigate selpercatinib, a newer RET inhibitor, reflecting significant research interest in this medication. The studies span multiple European countries, with France, Germany, Italy, and Spain hosting the most trials.
A notable feature is the inclusion of pediatric populations in two studies, addressing the need for treatment options for young patients aged 12 and older. The trials employ different research approaches, from dose optimization studies to head-to-head comparisons of multiple medications, providing comprehensive data on various treatment strategies.
All studies focus on advanced or metastatic disease, particularly in patients whose cancer is progressing or who have limited treatment options. The geographic distribution across Central and Western Europe, including Croatia, Romania, Poland, Hungary, Belgium, Netherlands, Greece, Czechia, and Denmark, offers broad access to these investigational treatments for European patients.
