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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
Patients with other gastrointestinal neuroendocrine tumors must have had progressive disease over the last 12 months irrespective of number of prior therapies. Patients with both functional (who may continue somatostatin analogues as required for control of related symptoms) and non-functional tumors are eligible
Histologically or cytologically confirmed unresectable well differentiated (irrespective of grade) carcinoid tumors. Patients with multiple neuroendocrine tumors associated with MEN1 syndrome will be eligible
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 below
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My gastrointestinal neuroendocrine tumor has worsened in the past year.
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I have a confirmed diagnosis of a specific type of tumor that cannot be surgically removed.
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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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I have waited the required time after my last chemotherapy before starting a new treatment.
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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.
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I have waited long enough after my last cancer treatment to start a new one.
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It has been over 4 weeks since my last biologic therapy.

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

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 • 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%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
18%
Pain in extremity
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Musculoskeletal chest pain
12%
Dry skin
12%
Anaemia
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Thrombocytopenia
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
8%
Hypomagnesaemia
7%
Haematuria
7%
Malaise
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
7%
Ejection fraction decreased
7%
Hyponatraemia
7%
Pruritus
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Influenza
6%
Dysuria
5%
Non-cardiac chest pain
5%
Hypothyroidism
5%
Haemoptysis
5%
Productive cough
5%
White blood cell count decreased
5%
Paraesthesia
5%
Pneumonia
3%
General physical health deterioration
2%
Pulmonary embolism
2%
Cholecystitis
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Malignant pleural effusion
2%
Spinal cord compression
2%
Acute kidney injury
2%
Sepsis
1%
Death
1%
Small intestinal obstruction
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
1%
Hypercalcaemia
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Intestinal obstruction
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Blood uric acid increased
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Hepatic failure
1%
Liver injury
1%
Diverticulitis
1%
Appendicitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Intracranial tumour haemorrhage
1%
Malignant neoplasm progression
1%
Bone pain
1%
Osteoarthritis
1%
Cancer pain
1%
Monoparesis
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
1%
Acute coronary 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

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
13,609 Previous Clinical Trials
40,915,610 Total Patients Enrolled
40 Trials studying Carcinoid Tumor
2,976 Patients Enrolled for Carcinoid Tumor
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,413 Total Patients Enrolled
5 Trials studying Carcinoid Tumor
284 Patients Enrolled for Carcinoid Tumor
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
Carcinoid Tumor Research Study Groups: 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
~2 spots leftby Jun 2024