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Sorafenib + Everolimus for Thyroid Cancer
Study Summary
This trial is testing whether adding everolimus to sorafenib tosylate helps treat patients with radioactive iodine refractory thyroid cancer better than sorafenib tosylate alone.
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.Side effects data
From 2015 Phase 2 trial • 25 Patients • NCT01189370Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I have never used sorafenib or mTOR inhibitors for thyroid cancer.I have never had cancer spread to my brain.My thyroid cancer has been confirmed to be Hürthle cell type.I can take care of myself but might not be able to do heavy physical work.I have never had chronic active hepatitis.I have not had a GI fistula or perforation in the last 90 days.I do not have a history of prolonged QT syndrome.Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your platelet count is at least 100,000 per cubic millimeter.I haven't had a heart attack, severe heart failure, stroke, severe circulation problems, or major blood clots in the last 6 months.I can provide 10 slides or a tumor block of my thyroid for review.My cancer has spread or cannot be removed by surgery.I had chemotherapy more than 28 days ago.I have received multiple treatments for my condition.I had radiation therapy over 28 days ago and my cancer has grown since then.I have not had major surgery in the last 4 weeks.My high blood pressure is under control with medication.You have a sufficient number of a type of white blood cell called neutrophils.My liver is functioning well, without severe disease.Patients must have a way to measure their disease using specific criteria.Your cholesterol level when fasting is less than or equal to 300 mg/dL.I am not on any strong CYP3A4 inhibitors.You need to have a negative pregnancy test no more than 7 days before joining the study.Your SGOT (AST) levels in the blood should not be more than 2.5 times the upper limit of normal.I am on a stable dose of blood thinner medication.My condition did not improve after radioactive iodine treatment.My kidney function is normal or only slightly reduced.I am not pregnant or breastfeeding.I had RAI therapy over 90 days ago and my condition has worsened since.My cancer has worsened in the last 14 months according to RECIST.I am not on any strong medication that affects liver enzyme levels.I had radiation therapy on areas other than the main tumor site more than 28 days ago.
- Group 1: sorafenib
- Group 2: sorafenib and everolimus
- 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
Are there multiple research centers participating in this trial across North America?
"This medical trial is presently offered at 21 sites, including New york City, Columbus and Goldsboro. To minimize travel requirements for participants, it is essential to select the most proximate location available."
Has the FDA sanctioned sorafenib for clinical use?
"Due to the lack of clinical evidence displaying sorafenib's efficacy and some data indicating its safety, it was given a score of 2."
Are individuals currently signing up to be part of this scientific experiment?
"Currently, this clinical trial is not enrolling patients. Initially posted on October 1st 2014 and most recently updated on March 11th 2022, those who are looking for alternative trials can explore the 226 studies actively recruiting participants with thyroid adenomas or 147 investigations that require sorafenib intake."
What similar experiments have been completed using sorafenib?
"At present, there are 147 studies underway concerning sorafenib with 37 of them in their third stage. The majority of these clinical trials for the drug take place in Taibei, Taiwan; however, it is being tested at 6596 different facilities globally."
In what circumstances is sorafenib typically prescribed?
"Sorafenib is frequently prescribed to mitigate the risk of kidney transplant rejection, but also has effectiveness in treating hemangiosarcoma, waldenstrom macroglobulinemia and certain lung conditions."
How many people are currently engaged in this test?
"Recruitment for this clinical trial has been terminated. It was initially advertised on 10/1/2014 and the information was last modified 3/11/2022. Should you be seeking other studies, there are 226 trials currently accepting participants with thyroid adenoma and 147 trials recruiting patients who need sorafenib treatments."
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