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
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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:
- 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
Citations
Study of Everolimus and Sorafenib in Patients With ...
The goal of this study is to determine the effect of combining everolimus and sorafenib in patients with metastatic differentiated thyroid cancer who progressed ...
Evaluating the Combination of Everolimus and Sorafenib in ...
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and everolimus will have on your thyroid cancer.
Combination of everolimus and sorafenib in the treatment ...
Conclusions: The combination of sorafenib and everolimus demonstrates activity that rivals the best reported data, and surpasses that for sorafenib alone, in ...
Enhanced antitumor efficacy of sorafenib and everolimus ...
In summary, our study reveals the anti-tumor effects of sorafenib, with an enhanced inhibition of pNENs growth and metastasis when combined with everolimus.
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allianceforclinicaltrialsinoncology.org
allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=/Public/News-Thyroid-A091302-Aug2018Alliance A091302
The FDA approved the use of sorafenib for the treatment of thyroid cancer based on a significant improvement in progression-free survival over placebo (10.8 ...
Sorafenib in radioactive iodine-refractory well-differentiated ...
Recent reviews and a meta-analysis reveal a modest ability to induce a partial remission but substantial ability to halt disease progression. Given the ...
Randomized phase II study of sorafenib with or without ...
In addition, a phase II study of sorafenib (S) and everolimus (E) showed promising data in HCC. A study to evaluate this was initiated through ...
Efficacy and safety of targeted therapeutics for patients with ...
The overall prognosis of thyroid cancer is usually favorable, with a 10-year survival rate up to 97% (Ito et al., 2018). Majority of patients ...
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