Lenvatinib for Advanced Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This research is being done to evaluate the safety and efficacy of neoadjuvant lenvatinib on surgical outcomes of patients with invasive extrathyroidal differentiated thyroid cancer (DTC).This research study involves a study drug called lenvatinib
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've had anticoagulant or antiplatelet therapy (except aspirin 81 mg daily) within 30 days prior to the study. It's best to discuss your current medications with the study team.
What safety data is available for Lenvatinib in treating advanced thyroid cancer?
Lenvatinib, also known as Lenvima, has been studied extensively for its safety profile in treating advanced thyroid cancer. Common adverse events include hypertension, proteinuria, diarrhea, appetite decrease, weight loss, nausea, and stomatitis. In the SELECT trial, most patients experienced adverse events, and dose reduction was required in 35-68% of patients, although only 15% withdrew due to toxicity. Long-term safety data from real-life experiences and expert consensus highlight the need for careful management of these adverse events to ensure continued therapy.12345
Is the drug Lenvatinib a promising treatment for advanced thyroid cancer?
What data supports the idea that Lenvatinib for Advanced Thyroid Cancer is an effective drug?
The available research shows that Lenvatinib is effective for treating advanced thyroid cancer. In a large study, patients who took Lenvatinib had a longer time before their cancer got worse compared to those who took a placebo, which is a pill with no medicine in it. This study involved 392 patients and showed that Lenvatinib significantly delayed the progression of the disease. Additionally, the drug has been approved by the FDA for this specific type of thyroid cancer, indicating its effectiveness. Overall, these findings suggest that Lenvatinib is a beneficial option for patients with advanced thyroid cancer.256910
Who Is on the Research Team?
Gregory Randolph, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary (MEEI)
Are You a Good Fit for This Trial?
This trial is for adults with advanced thyroid cancer who can swallow pills, have controlled blood pressure, and are not pregnant or breastfeeding. They must agree to use effective contraception and cannot have had certain treatments or conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant lenvatinib orally daily for 2, 4, or 6 cycles, each cycle being 28 days, prior to surgery
Surgery
Surgery to remove cancerous tumors (thyroidectomy) following lenvatinib treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lenvatinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor
Eisai Inc.
Industry Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University