Everolimus + Sorafenib for Thyroid Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that patients receiving certain treatments like corticosteroids or other immunosuppressive agents are excluded. It also suggests avoiding medications that affect CYP3A metabolism, such as some antibiotics and antifungals, if possible.

What data supports the effectiveness of the drugs Everolimus and Sorafenib for thyroid cancer?

Research shows that Sorafenib has been effective in treating advanced thyroid cancer by stopping cancer cell growth and blood vessel formation. Everolimus has shown promise in treating thyroid cancer that doesn't respond to traditional treatments, with some patients experiencing stable disease or partial responses. ^{1 2 3 4 5}

Is the combination of Everolimus and Sorafenib safe for treating thyroid cancer?

Sorafenib has been studied for thyroid cancer and is generally considered safe, but it can cause side effects like skin reactions, diarrhea, and hair loss. Everolimus has shown promise in treating thyroid cancer, but specific safety data for the combination of Everolimus and Sorafenib is not available in the provided research. ^{2 4 6 7 8}

How is the drug combination of Everolimus and Sorafenib unique for treating thyroid cancer?

The combination of Everolimus and Sorafenib is unique for treating thyroid cancer because it targets different pathways involved in cancer growth. Everolimus inhibits the mTOR pathway, which is often upregulated in thyroid tumors, while Sorafenib blocks multiple kinases involved in tumor cell proliferation and blood vessel formation, making it a promising option for advanced thyroid cancer not responsive to traditional treatments. ^{2 3 4 5 7}

Research Team

Eric Sherman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I have not had major surgery or significant injury in the last 4 weeks.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of sorafenib and everolimus to evaluate effects on thyroid cancer

12 weeks

Weekly visits for safety and toxicity assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Everolimus
• Sorafenib

Trial Overview 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.

Participant Groups

Group I: sorafenib with everolimus Experimental Treatment 1 Intervention

This is a two-stage phase II study combining sorafenib with everolimus in patients with thyroid cancer.

Everolimus is already approved in United States, European Union for the following indications:

Approved in United States as Afinitor for:

• Advanced renal cell carcinoma
• Subependymal giant cell astrocytoma
• Progressive neuroendocrine tumors of pancreatic origin
• Advanced hormone receptor-positive, HER2-negative breast cancer
• Tuberous sclerosis complex-associated partial-onset seizures

Approved in European Union as Votubia for:

• Subependymal giant cell astrocytoma
• Renal angiomyolipoma
• Tuberous sclerosis complex-associated partial-onset seizures

Approved in United States as Zortress for:

• Prevention of organ rejection in kidney transplant patients

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. England pubmed.ncbi.nlm.nih.gov

A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Sorafenib and thyroid cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Genomic Correlates of Response to Everolimus in Aggressive Radioiodine-refractory Thyroid Cancer: A Phase II Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Everolimus in Patients With Advanced Follicular-Derived Thyroid Cancer: Results of a Phase II Clinical Trial. [2019]

5. Italy pubmed.ncbi.nlm.nih.gov

Aggressive thyroid cancer: targeted therapy with sorafenib. [2021]

6. France pubmed.ncbi.nlm.nih.gov

Sorafenib: a review of its use in patients with radioactive iodine-refractory, metastatic differentiated thyroid carcinoma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sorafenib in Japanese Patients with Locally Advanced or Metastatic Medullary Thyroid Carcinoma and Anaplastic Thyroid Carcinoma. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Multicenter Randomized Phase II Study of Single Agent Efficacy and Optimal Combination Sequence of Everolimus and Pasireotide LAR in Advanced Thyroid Cancer. [2022]