Everolimus + Sorafenib for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effects of combining two oral medications, sorafenib and everolimus, on thyroid cancer that cannot be surgically removed or has spread. Sorafenib (Nexavar) cuts off the tumor's blood supply, while everolimus (Afinitor, Votubia, or Zortress) targets specific proteins to halt cancer growth. Researchers believe that using both drugs together might outperform sorafenib alone. The trial seeks participants with thyroid cancer that has worsened or returned after other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is investigating the safety and effectiveness of combining everolimus and sorafenib for treating thyroid cancer. The FDA has already approved these drugs for kidney cancer, and sorafenib is also approved for liver cancer, confirming their safety for these uses.
In these studies, researchers are testing whether this drug combination can halt the growth of thyroid cancer. While the primary focus is on the drugs' effectiveness together, safety remains crucial. Reports indicate that sorafenib can cause side effects such as diarrhea and skin reactions on the hands and feet. Everolimus may lead to mouth sores and fatigue. However, medical intervention can usually manage these side effects.
Overall, current research suggests that using these two drugs together shows promise. As with any treatment, side effects may occur. Discuss any concerns with the trial team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining everolimus and sorafenib for thyroid cancer because it offers a unique dual-targeted approach. Unlike standard treatments, which often focus on a single pathway, this combination targets both mTOR and RAF kinase pathways, potentially disrupting the cancer's growth and spread more effectively. This dual action could lead to better outcomes for patients who haven't responded well to existing therapies. Plus, by interrupting two critical cancer growth processes, the treatment might reduce the chance of resistance developing, offering a new hope for long-term management of thyroid cancer.
What evidence suggests that the combination of everolimus and sorafenib could be an effective treatment for thyroid cancer?
This trial will evaluate the combination of two drugs, everolimus and sorafenib, for treating thyroid cancer. Sorafenib, already approved for this type of cancer, cuts off the blood supply to tumors, helping to stop their growth. Everolimus blocks a protein that aids cancer cell growth. Studies have suggested that using these two drugs together might be more effective than using sorafenib alone. This combination has demonstrated effectiveness comparable to some of the best treatments currently available for thyroid cancer. Early findings indicate that these two drugs together might better control the cancer's progression.12678
Who Is on the Research Team?
Eric Sherman, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of sorafenib and everolimus to evaluate effects on thyroid cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Everolimus
- Sorafenib
Everolimus is already approved in United States, European Union for the following indications:
- 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
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
- Prevention of organ rejection in kidney transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor