What is the mechanism of action of this treatment?

Common treatments for thyroid cancer, such as Sorafenib and Everolimus, work by targeting specific pathways that tumors use to grow and survive. Sorafenib decreases the blood supply to tumors, limiting their access to essential nutrients and oxygen, which inhibits their growth. Everolimus inhibits the mTOR protein kinase, a key player in cell growth and proliferation, thereby reducing tumor growth. These targeted mechanisms are important for thyroid cancer patients as they offer a strategic approach to disrupt the cancer's growth and improve treatment outcomes.

What side effects are associated with this type of intervention?

Common treatments for thyroid cancer, such as Sorafenib and Everolimus, have distinct side effect profiles. Sorafenib often causes hypertension, diarrhea, fatigue, hand-foot skin reactions, and rash. Everolimus typically leads to stomatitis, infections, rash, fatigue, diarrhea, and hyperglycemia. When used in combination, these drugs may increase the likelihood and severity of these side effects, necessitating careful patient monitoring.

What prior FDA approvals exist?

Sorafenib, a tyrosine kinase inhibitor that decreases the blood supply to tumors, is FDA-approved for the treatment of thyroid cancer. It works by limiting the tumor's source of oxygen and nutrients, thereby preventing its growth. Everolimus, an mTOR inhibitor, is FDA-approved for the treatment of kidney cancer and is being studied for its effectiveness in combination with sorafenib for thyroid cancer. These drugs represent targeted therapies aimed at disrupting specific pathways critical for tumor growth and survival.

What other types of research exist?

Promising alternatives to Sorafenib and Everolimus for thyroid cancer treatment include selective RET inhibitors such as selpercatinib and pralsetinib, which are effective in RET-mutated medullary thyroid cancer. Additionally, antiangiogenic multikinase inhibitors like vandetanib and cabozantinib have shown efficacy in treating thyroid cancer by targeting multiple pathways involved in tumor growth and angiogenesis.

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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.

Must not have

Serious or non-healing wound, ulcer, or bone fracture.

Patients with an active, bleeding diathesis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once a week

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two pills, sorafenib and everolimus, to treat thyroid cancer. Sorafenib cuts off the tumor's blood supply, while everolimus blocks a protein that helps cancer cells grow. Everolimus is approved for various cancers, including breast cancer, and has shown promise in combination therapies. The study aims to see if this combination works better than current treatments.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious wounds, ulcers, or unhealed bone fractures.

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I do not have a condition that causes excessive bleeding.

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I am not allergic to RAD001 (everolimus) or similar medications.

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I do not have liver disease, severe infections, or uncontrolled illnesses.

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I do not have stomach or bowel problems that could affect how my body absorbs medication.

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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.

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I have been diagnosed with HIV.

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I am on long-term steroids or other drugs that weaken my immune system.

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I have been treated with mTOR inhibitors or sorafenib for thyroid cancer.

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I have serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ once a week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~once a week

This trial's timeline: 3 weeks for screening, Varies for treatment, and once a week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Assess safety and toxicity.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for thyroid cancer, such as Sorafenib and Everolimus, work by targeting specific pathways that tumors use to grow and survive. Sorafenib decreases the blood supply to tumors, limiting their access to essential nutrients and oxygen, which inhibits their growth. Everolimus inhibits the mTOR protein kinase, a key player in cell growth and proliferation, thereby reducing tumor growth. These targeted mechanisms are important for thyroid cancer patients as they offer a strategic approach to disrupt the cancer's growth and improve treatment outcomes.

Rapamycin weekly maintenance dosing and the potential efficacy of combination sorafenib plus rapamycin but not atorvastatin or doxycycline in tuberous sclerosis preclinical models.