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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
Must not have
Patient has had major surgery within 21 days prior to starting study drug or has not recovered from major side effects
Patients with concurrent malignancies or malignancies within 3 years prior to starting study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of study treatment
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial studies how well lenvatinib and everolimus work in treating patients with advanced carcinoid tumors that cannot be removed by surgery. These medications are taken by mouth and aim to stop cancer cells from growing by blocking essential enzymes. The trial will evaluate how effective and safe these drugs are for these patients. Both lenvatinib and everolimus have shown effectiveness in treating various cancers.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 3 weeks or still have major side effects from it.
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I haven't had any other cancers in the last 3 years.
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I have or might have cancer that has spread to my brain.
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I have coughed up bright red blood recently.
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I had radiotherapy recently and still experience significant side effects.
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I have been diagnosed with HIV, hepatitis B, or hepatitis C.
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I am currently taking warfarin or a similar blood thinner.
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I have previously been treated with mTOR inhibitors or lenvatinib.
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I am allergic to lenvatinib, everolimus, or their ingredients.
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I am a sexually active male and will use a condom during treatment and for 28 days after.
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I have heart problems that affect my daily activities.
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I cannot take pills by mouth or have a stomach condition that affects medication absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic response rate
Secondary study objectives
Incidence of adverse events

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT01321554
70%
Diarrhoea
69%
Hypertension
57%
Decreased appetite
54%
Weight decreased
49%
Nausea
44%
Fatigue
40%
Headache
38%
Proteinuria
38%
Vomiting
38%
Stomatitis
33%
Palmar-plantar erythrodysaesthesia syndrome
33%
Arthralgia
33%
Dysphonia
32%
Constipation
30%
Cough
26%
Asthenia
25%
Oedema peripheral
21%
Rash
20%
Back pain
20%
Myalgia
19%
Abdominal pain
18%
Abdominal pain upper
18%
Pain in extremity
18%
Dysgeusia
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Dyspepsia
15%
Hypocalcaemia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Thrombocytopenia
10%
Oral pain
10%
Hypoalbuminaemia
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Depression
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Malaise
7%
Haematuria
7%
Ejection fraction decreased
7%
Pruritus
7%
Hyponatraemia
7%
Blood thyroid stimulating hormone increased
7%
Platelet count decreased
7%
Aspartate aminotransferase increased
7%
Toothache
7%
Glossodynia
7%
Blood alkaline phosphatase increased
7%
Hyperkeratosis
7%
Bronchitis
6%
Flatulence
6%
Influenza
6%
Dysuria
6%
Anxiety
6%
Hyperglycaemia
6%
Leukopenia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Paraesthesia
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Sepsis
2%
Cholecystitis
2%
Pulmonary embolism
2%
Malignant pleural effusion
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Spinal cord compression
2%
Acute kidney injury
1%
Blood uric acid increased
1%
Monoparesis
1%
Acute respiratory failure
1%
Hypercalcaemia
1%
Hepatic failure
1%
Acute coronary syndrome
1%
Appendicitis
1%
Death
1%
Respiratory failure
1%
Osteoarthritis
1%
Intestinal obstruction
1%
Small intestinal obstruction
1%
Intracranial tumour haemorrhage
1%
Colitis
1%
Transient ischaemic attack
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Liver injury
1%
Diverticulitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
OOL, Treatment Period: Lenvatinib 20 mg

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Carcinoid Tumor treatments often involve Receptor Tyrosine Kinase Inhibitors (RTKIs) like lenvatinib and mTOR inhibitors like everolimus. RTKIs work by blocking the activity of enzymes called tyrosine kinases, which are involved in the signaling pathways that promote tumor cell growth and angiogenesis (formation of new blood vessels). By inhibiting these pathways, RTKIs can reduce tumor growth and spread. mTOR inhibitors, on the other hand, target the mTOR pathway, which is crucial for cell growth, proliferation, and survival. Inhibiting mTOR can lead to reduced tumor cell proliferation and increased cell death. These mechanisms are particularly important for Carcinoid Tumor patients as they offer targeted approaches to slow down or stop tumor progression, potentially improving survival and quality of life.
Therapeutic strategies for patients with neuroendocrine neoplasms: current perspectives.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,152 Total Patients Enrolled
7 Trials studying Multiple Endocrine Neoplasia
266 Patients Enrolled for Multiple Endocrine Neoplasia
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,772 Total Patients Enrolled
5 Trials studying Multiple Endocrine Neoplasia
2,319 Patients Enrolled for Multiple Endocrine Neoplasia
Nageshwara V DasariPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Everolimus (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03950609 — Phase 2
Multiple Endocrine Neoplasia Research Study Groups: Treatment (lenvatinib, everolimus)
~3 spots leftby Jun 2025