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Lenvatinib + Everolimus for Neuroendocrine Tumors
Study Summary
This trial will study how well lenvatinib and everolimus work in treating patients with unresectable carcinoid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 392 Patients • NCT01321554Trial Design
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- I haven't had major surgery in the last 3 weeks or still have major side effects from it.I am willing and able to follow the study's requirements.Your platelet count is at least 100 billion per liter.I haven't had any other cancers in the last 3 years.I have or might have cancer that has spread to my brain.I have coughed up bright red blood recently.I had radiotherapy recently and still experience significant side effects.Your hemoglobin level is at least 9 grams per deciliter.Your total bilirubin level in the blood is not more than 1.5 times the upper limit of normal.I have a confirmed diagnosis of a specific type of tumor that cannot be surgically removed.I have protein in my urine and will need a 24-hour test to measure it.Your platelet count is at least 100 billion per liter.I have no active cancer except for certain skin cancers or early-stage cervical or bladder cancer.My gastrointestinal neuroendocrine tumor has worsened in the past year.I have waited the required time after my last chemotherapy before starting a new treatment.My cancer can be seen on scans and has grown after specific treatments.My gastrointestinal neuroendocrine tumor has worsened in the past year.Your hemoglobin level is at least 9 grams per deciliter.I have been diagnosed with HIV, hepatitis B, or hepatitis C.I am currently taking warfarin or a similar blood thinner.I have previously been treated with mTOR inhibitors or lenvatinib.Your absolute neutrophil count is equal to or greater than 1.5 x 10^9/L.I am allergic to lenvatinib, everolimus, or their ingredients.Your blood levels of certain minerals must be within normal limits.My lung function tests show at least half the normal capacity and my oxygen levels are above 88% without assistance.My cancer can be seen on scans and has grown after specific treatments.Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study treatment.I have waited the required time after my last chemotherapy before starting a new treatment.I am a sexually active male and will use a condom during treatment and for 28 days after.I have heart problems that affect my daily activities.My kidney function is within the normal range.My liver tests are within the required range.I am using effective birth control and will continue for 8 weeks after the study ends.I am fully active or restricted in physically strenuous activity but can do light work.I cannot take pills by mouth or have a stomach condition that affects medication absorption.It has been over 4 weeks since my last biologic therapy.I have a confirmed carcinoid tumor that cannot be surgically removed.I am fully active or restricted in physically strenuous activity but can do light work.I have waited long enough after my last cancer treatment to start a new one.It has been over 4 weeks since my last biologic therapy.Your absolute neutrophil count is at least 1.5 x 10^9 per liter.
- Group 1: Treatment (lenvatinib, everolimus)
Frequently Asked Questions
What have been the most adverse effects of Lenvatinib in human trials?
"While Phase 2 trials don't have the same level of data supporting efficacy, Lenvatinib still received a score of 2 for safety."
Are there any patients required for this research?
"That is correct. The information available on clinicaltrials.gov seems to suggest that this study, which was first posted on 7/30/2019, is still recruiting patients. They are admitting 32 participants from 1 location."
What are the primary conditions that Lenvatinib is used to treat?
"Lenvatinib is most commonly used to treat liver transplant rejection but can also help patients manage kidney transplant rejection, waldenstrom macroglobulinemia, and lung conditions."
Are there other examples in the literature of Lenvatinib being used?
"There are a total of 244 studies currently underway that focus on Lenvatinib. Out of those, 47 trials have reached Phase 3. While the concentration of research is in Nanning, Guangxi, there are 8724 locations running clinical trials for this treatment globally."
How many people are being welcomed into this clinical research project?
"Yes, the study is open for recruitment and has updated their information as recently as September 22nd, 2022. According to the data, they are looking for 32 patients at a single location."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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