Sorafenib + Everolimus for Thyroid Cancer

Recruiting in Columbus (<10 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies the effects, good and bad, of using everolimus along with sorafenib tosylate versus sorafenib tosylate alone in treating patients with advanced radioactive iodine refractory thyroid cancer. Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of everolimus to sorafenib tosylate may cause more shrinkage of thyroid cancer and may prevent it from growing but it could also cause more side effects than sorafenib tosylate alone. It is not yet known whether this treatment with sorafenib tosylate and everolimus is better, the same, or worse than sorafenib tosylate alone.

Research Team

Eric Sherman, M.D.

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with advanced Hurthle cell thyroid cancer that hasn't responded to radioactive iodine treatment can join. They should have measurable disease, no recent major surgery, and their blood counts and liver function need to be within certain limits. No prior sorafenib or mTOR inhibitors for thyroid cancer, no brain metastasis, and a good performance status are required.

Inclusion Criteria

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.

Exclusion Criteria

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.

Treatment Details

Interventions

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

Trial Overview The trial is testing if adding everolimus to sorafenib tosylate improves outcomes in patients with this type of thyroid cancer. Participants will either receive both drugs or only sorafenib tosylate, randomly assigned, to see which approach is more effective at stopping tumor growth.

Participant Groups

Group I: sorafenib and everolimus Experimental Treatment 2 Interventions

Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: sorafenib Active Control 1 Intervention

Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania