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Kinase Inhibitor
Everolimus + Sorafenib for Thyroid Cancer
Phase 2
Waitlist Available
Led By Eric Sherman, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2 (or Karnofsky performance status ≥ 60%).
Age 18 years old or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study the effects of the combination of sorafenib and everolimus on thyroid cancer.
Who is the study for?
Adults with confirmed thyroid cancer that's inoperable or has spread, and who haven't had certain recent treatments or surgeries. They must be able to undergo biopsies, have a PET scan showing at least one lesion, measurable disease progression, acceptable organ function, and controlled cholesterol levels. Pregnant women and those with specific health conditions like anaplastic thyroid carcinoma or active brain metastasis are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: sorafenib (a pill approved for kidney and liver cancers) which cuts off blood supply to tumors; and everolimus (an oral medication for kidney cancer) which inhibits mTOR protein kinase. The study aims to see if taking these drugs together works better than just sorafenib alone for treating thyroid cancer.See study design
What are the potential side effects?
Potential side effects include risks associated with decreased blood supply to tumors such as fatigue and weakness, issues from inhibiting mTOR like mouth sores or lung problems, digestive disturbances, changes in blood counts leading to increased infection risk, high cholesterol levels, skin reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My cancer is getting worse despite treatment.
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My thyroid cancer was confirmed by a biopsy at MSKCC.
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I agree to two biopsies of my cancer that can be seen with ultrasound.
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My disease cannot be removed by surgery and/or has spread.
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I have had a PET scan showing at least one active cancer spot that hasn't been treated with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the response rate of the combination sorafenib and everolimus.
Secondary outcome measures
Assess safety and toxicity.
Determine the progression free survival under the combination of sorafenib and everolimus.
Evaluate if mutations in the pTEN, PI3K AKT, mTOR pathway, predict response to therapy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: sorafenib with everolimusExperimental Treatment1 Intervention
This is a two-stage phase II study combining sorafenib with everolimus in patients with thyroid cancer.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,579 Total Patients Enrolled
Eric Sherman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or significant injury in the last 4 weeks.I have had radiation therapy before, under specific conditions.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I have been diagnosed with anaplastic thyroid cancer in the last year.I have not had any live vaccines in the week before or during the study.I do not have any serious wounds, ulcers, or unhealed bone fractures.My cancer is getting worse despite treatment.I have previously undergone RAI therapy under specific conditions.I do not have a condition that causes excessive bleeding.I am not allergic to RAD001 (everolimus) or similar medications.Your cholesterol and triglyceride levels must be within certain limits, even if you haven't eaten for a while.I have not had any major abdominal issues like a fistula, perforation, or abscess in the last 28 days.I do not have liver disease, severe infections, or uncontrolled illnesses.I avoid medications that affect CYP3A metabolism, if possible.My thyroid cancer was confirmed by a biopsy at MSKCC.I agree to two biopsies of my cancer that can be seen with ultrasound.My disease cannot be removed by surgery and/or has spread.My organ and bone marrow functions are normal.I do not have stomach or bowel problems that could affect how my body absorbs medication.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.I have had active brain metastasis in the last 3 months.I am willing and able to follow the study's requirements.I have been diagnosed with HIV.You must have a disease that can be measured using specific criteria.I am on long-term steroids or other drugs that weaken my immune system.I have been treated with mTOR inhibitors or sorafenib for thyroid cancer.I haven't had cancer treatment in the last 4 weeks.I have serious heart problems.I have had a PET scan showing at least one active cancer spot that hasn't been treated with surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: sorafenib with everolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How potentially hazardous is the combination of sorafenib and everolimus for individuals?
"Our internal evaluation rated the safety of sorafenib and everolimus as a 2. This is because, while there are data points that demonstrate its security profile, no evidence exists which supports its efficacy."
Answered by AI
In what clinical contexts is the combination of sorafenib and everolimus typically employed?
"Sorafenib combined with everolimus can be deployed to reject kidneys during transplant, as well as combat conditions such as hemangiosarcoma, waldenstrom macroglobulinemia and lung-based ailments."
Answered by AI
Has a combination of sorafenib and everolimus been investigated in previous research trials?
"Currently, sorafenib with everolimus is being trialled in 147 different clinical studies. Of these active trials, 37 are at the Phase 3 stage of drug development. The majority of these investigations are situated in Taibei, Taiwan; however this treatment is also being examined across 6596 other medical centres worldwide."
Answered by AI
Are there any recruitment opportunities for this research endeavor?
"The clinicaltrial.gov database reports that this medical study is no longer recruiting patients, having been posted on June 1st 2010 and last updated July 1st 2022. While the trial has ended recruitment, there are currently 377 other trials actively enrolling participants."
Answered by AI
How many individuals have been enrolled in this research initiative?
"This research opportunity is no longer open to applicants. It was initially posted on June 1st, 2010 and the listing expired on July 1st 2022. For individuals seeking alternate clinical trials for thyroid cancer, there are 230 options enrolling patients currently; an additional 147 studies include Sorafenib with Everolimus as a treatment option."
Answered by AI
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