Everolimus + Sorafenib for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Eric Sherman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

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.

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.

Treatment Details

Interventions

• Everolimus (Kinase Inhibitor)
• Sorafenib (Kinase Inhibitor)

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University