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Selpercatinib Before Surgery for Thyroid Cancer
Study Summary
This trial is studying the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can care for myself and remain up and about more than half of my waking hours.I have uncontrolled high or low calcium levels causing symptoms.You had a very strong allergic reaction (grade 3 or higher) to selpercatinib or any of its ingredients.I do not have any uncontrolled infections or serious illnesses like high blood pressure or diabetes.Your hemoglobin level is at least 9 grams per deciliter.Your platelet count is at least 100,000 per microliter.I am at least 12 years old.You have at least one specific area of disease that can be measured according to certain guidelines.I am taking medication that can affect my heart's rhythm.I agree to use effective birth control during and for 3 months after treatment.My blood levels of potassium, calcium, and magnesium are normal, or I am taking supplements to maintain them.My thyroid cancer is advanced or has come back, and it may have spread.I have had targeted radiation for symptom relief within the last week, not affecting more than 30% of my bone marrow.I have symptoms from a brain tumor, brain metastases, cancer in my spinal fluid, or untreated spinal cord compression.I have a condition that affects how my body absorbs medication.I have taken drugs for cancer that target multiple proteins before.My surgery is considered to have a moderate to unresectable complexity level.My liver enzymes are within acceptable limits, even with cancer in my liver.Your white blood cell count is at least 1500 per microliter.I haven't taken any cancer treatment within the last 3 weeks or 5 half-lives, whichever is shorter.My cancer has a mutation that may not respond to selpercatinib treatment.I have been treated with a specific medication for cancer targeting the RET gene.I haven't had a heart attack or serious heart issues in the last 6 months.My thyroid condition is not under control and causes symptoms.I haven't had major surgery in the last 4 weeks.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum therapy.My cancer has a specific genetic change called RET alteration.I am willing to have a tumor biopsy and surgery if my doctor thinks it's safe and necessary.I have another cancer besides the one being studied, but it's slow-growing and not being actively treated.Your total bilirubin level in the blood should not be higher than 1.5 times the upper limit of normal, unless you have a history of Gilbert syndrome, in which case it should not be higher than 3 times the upper limit of normal.My thyroid cancer diagnosis fits one of the specified types.
- Group 1: Treatment (selpercatinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial represent a new development in medical research?
"584 cities and 34 countries are presently host to 11 active studies for Selpercatinib. The very first trial was completed in 2017 by Eli Lilly and Company. That study saw 875 participants through its Phase 1 & 2 stages before completing drug approval. In the 4 years since, 273 more trials have been completed."
How many people are being welcomed into this research project?
"That is correct, the trial is still open and recruiting patients. Per information on clinicaltrials.gov, the study was first posted on February 26th, 2021 and was last updated on October 11th, 2022. They are hoping to enroll 30 individuals at a single location."
What are the goals and objectives of this clinical trial?
"The primary goal of this clinical trial, which will last for up to 7 months, is to assess the Objective response rate (ORR). Secondary outcomes include the surgical morbidity/complexity score and patient-reported outcomes. The surgical morbidity/complexity score will be measured at enrollment, prior to surgery and at surgery; descriptive statistics such as means and standard deviations will be calculated for each time point. Progression free survival (PFS) is defined as the time from patient registration to disease progression or death from any cause."
Are there many case studies of Selpercatinib's efficacy?
"As of now, there are 11 different ongoing Selpercatinib trials. Out of those, 3 are in Phase 3. Even though the majority of these studies taking place in Siena, Italy, there are a total of 1576 research sites for this medication."
What has been Selpercatinib's impact on patients in terms of safety?
"Selpercatinib's safety was rated a 2 by our team because there is some evidence that it is safe, but none to support that it is effective."
What are the primary conditions that Selpercatinib has been show to be effective for?
"Selpercatinib is a common medication used to treat medullary carcinoma of thyroid. It can also be effective in managing other adrenal medulla, radioactive iodine-refractory, and require systemic therapy."
Are we currently looking for more participants for this experiment?
"This clinical trial is still recruiting participants, according to the information on ClinicalTrials.gov. The trial was originally posted on February 26th, 2021, and was last edited on October 11th, 2022."
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