Vandetanib + Everolimus for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and assess the side effects of combining vandetanib and everolimus for treating advanced cancer that has spread. These drugs may inhibit cancer growth by blocking specific enzymes essential for cancer cell proliferation. The trial seeks participants whose cancer has not responded to standard treatments or who lack other treatment options that could extend survival by at least three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be at least 3 weeks past your last chemotherapy and radiation treatments, and 5 half-lives or 3 weeks past any targeted or biologic therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using vandetanib and everolimus together is generally safe for treating advanced cancers. In past studies, adults and children with advanced cancers tolerated this combination well. The most common doses tested were 300 mg of vandetanib and 10 mg of everolimus.
Most side effects were manageable, though some negative effects occurred, such as tiredness or digestive issues. Serious problems were rare. Researchers are also testing this combination for other types of cancer, indicating confidence in its safety.
In summary, while this specific trial remains in an early stage, existing research supports the safety of these drugs when used together.12345Why are researchers excited about this trial's treatments?
Researchers are excited about vandetanib and everolimus for advanced cancer because these drugs target specific pathways involved in cancer growth. Vandetanib works by blocking signals that promote tumor cell division and blood vessel formation, while everolimus inhibits a protein that controls cell growth. This combination approach is different from current treatments that often focus on a single mechanism, potentially offering a more effective strategy to halt cancer progression. By attacking the cancer from multiple angles, these drugs might provide new hope for patients with limited options.
What evidence suggests that vandetanib and everolimus might be effective for advanced cancer?
Research has shown that using vandetanib and everolimus together may help treat advanced cancers. In this trial, participants will receive a combination of these two drugs. One study found that this combination helped patients live longer and reduced tumor size in some cases. In children with advanced cancers, this treatment proved effective and generally well-tolerated. Another study found that using both drugs together worked better than using either one alone for some patients with solid tumors. These findings suggest that vandetanib and everolimus together might benefit people with metastatic cancer.36789
Who Is on the Research Team?
Sarina Piha-Paul, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with advanced or metastatic cancer that's resistant to standard therapy, relapsed, or without a survival-improving standard option. They must be weeks past prior treatments, have adequate organ/marrow function and agree to use contraception. Exclusions include certain heart conditions, uncontrolled illnesses, pregnancy/lactation, and hypersensitivity to the drugs tested.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive vandetanib and everolimus orally once daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Everolimus
- Vandetanib
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?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator