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Kinase Inhibitor
Lenvatinib + Everolimus for Neuroendocrine Tumors
Phase 2
Waitlist Available
Led By Nageshwara V Dasari
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cytotoxic or targeted chemotherapy: >= the duration of the cycle of the most recent treatment regimen (a minimum of 3 weeks for all regimens, except 6 weeks for nitrosoureas and mitomycin-C)
Patients must have radiographically measurable disease. Lesions that have had locoregional therapies such as radiofrequency (RF) ablation, radiation or transarterial therapies must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of study treatment
Awards & highlights
Study Summary
This trial will study how well lenvatinib and everolimus work in treating patients with unresectable carcinoid tumors.
Who is the study for?
This trial is for patients with advanced, unresectable carcinoid tumors. Eligible participants must have well-differentiated tumors, may have MEN1 syndrome, and show disease progression over the last year. They should be in good physical condition (ECOG 0-1), not pregnant, able to swallow pills, without HIV or hepatitis B/C, and free from other cancers in the past 3 years.Check my eligibility
What is being tested?
The study tests lenvatinib and everolimus' effectiveness on advanced carcinoid tumors that can't be surgically removed. These drugs aim to inhibit tumor growth by blocking enzymes necessary for cell proliferation.See study design
What are the potential side effects?
Potential side effects of lenvatinib and everolimus include fatigue, diarrhea, high blood pressure, decreased appetite, weight loss, nausea/vomiting; some serious risks are heart damage or severe bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have waited the required time after my last chemotherapy before starting a new treatment.
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My cancer can be seen on scans and has grown after specific treatments.
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My lung function tests show at least half the normal capacity and my oxygen levels are above 88% without assistance.
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My cancer can be seen on scans and has grown after specific treatments.
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My kidney function is within the normal range.
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My liver tests are within the required range.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Radiographic response rate
Secondary outcome measures
Incidence of adverse events
Progression-free survival
Side effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155470%
Hypertension
70%
Diarrhoea
60%
Weight decreased
43%
Fatigue
43%
Stomatitis
40%
Arthralgia
40%
Proteinuria
40%
Nausea
37%
Decreased appetite
33%
Headache
33%
Asthenia
33%
Dysphonia
30%
Myalgia
30%
Palmar-plantar erythrodysaesthesia syndrome
30%
Abdominal pain upper
30%
Vomiting
27%
Cough
27%
Abdominal pain
27%
Dizziness
23%
Pain in extremity
20%
Alopecia
20%
Back pain
20%
Rash
20%
Dysgeusia
20%
Nasopharyngitis
17%
Constipation
17%
Muscle spasms
17%
Dyspnoea
17%
Epistaxis
17%
Platelet count decreased
17%
Pyrexia
13%
Hypotension
13%
Oropharyngeal pain
13%
Musculoskeletal pain
10%
Anaemia
10%
Paraesthesia
10%
Flank pain
10%
Dyspepsia
10%
Dysphagia
10%
Sinusitis
10%
Oedema peripheral
10%
Pelvic pain
10%
Urinary tract infection
10%
Hypocalcaemia
10%
Musculoskeletal chest pain
10%
Haemoptysis
10%
Depression
10%
Upper respiratory tract infection
10%
Insomnia
7%
Skin fissures
7%
Vitamin D deficiency
7%
Ejection fraction decreased
7%
Pneumonia
7%
Hypomagnesaemia
7%
Joint swelling
7%
Bronchitis
7%
Blood cholesterol increased
7%
Dyspnoea exertional
7%
Hyperhidrosis
7%
Toothache
7%
Hyperaesthesia
7%
Sciatica
7%
Gastrooesophageal reflux disease
7%
Lung infection
7%
Dermatitis acneiform
7%
Hypothyroidism
7%
Alanine aminotransferase increased
7%
Dry skin
7%
Flatulence
7%
Productive cough
7%
Non-cardiac chest pain
7%
Abdominal distension
7%
Gingival pain
7%
Gastrointestinal infection
7%
Pain
7%
Lipase increased
3%
Blood calcium increased
3%
Electrocardiogram T wave inversion
3%
Hypoalbuminaemia
3%
Dementia
3%
Varicose vein
3%
Thermal burn
3%
Blood creatinine increased
3%
Electrocardiogram QT prolonged
3%
Post procedural haemorrhage
3%
Pathological fracture
3%
Syncope
3%
Cerebrovascular accident
3%
Phlebitis infective
3%
Haemorrhoids
3%
Cholecystitis acute
3%
Gastroenteritis
3%
Delirium
3%
General physical health deterioration
3%
Dry mouth
3%
Hyponatraemia
3%
Dehydration
3%
Coronary artery occlusion
3%
Lymph gland infection
3%
Metastatic pain
3%
Transient ischaemic attack
3%
Hydrocholecystis
3%
Vasculitis
3%
Hyperglycaemia
3%
Neck pain
3%
Thrombocytopenia
3%
Malaise
100%
80%
60%
40%
20%
0%
Study treatment Arm
OOL, Treatment Period: Lenvatinib 20 mg
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (lenvatinib, everolimus)Experimental Treatment2 Interventions
Patients receive lenvatinib PO daily and everolimus PO daily on days 1-28. Treatments repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Lenvatinib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,335 Total Patients Enrolled
40 Trials studying Carcinoid Tumor
2,976 Patients Enrolled for Carcinoid Tumor
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,472 Total Patients Enrolled
5 Trials studying Carcinoid Tumor
240 Patients Enrolled for Carcinoid Tumor
Nageshwara V DasariPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lenvatinib, everolimus)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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