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mTOR Inhibitor
Lenvatinib + Everolimus for Kidney Cancer
Phase 1
Waitlist Available
Led By Yousef Zakharia, MD
Research Sponsored by Yousef Zakharia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal function within normal institutional limit or creatinine clearance >30 mL/min/1.73 m2
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Must not have
Any other cancer from which the patient has been disease-free for less than 3 years
Symptomatic untreated metastases in the central nervous system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (within 14 days of day 1) and pre-surgery (week 9-10). 1) if metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death.
Awards & highlights
Summary
This trial is testing a combination of drugs to see if it can make previously inoperable tumors resectable in patients with kidney cancer.
Who is the study for?
Adults with advanced or metastatic renal cell carcinoma, clear cell type, who may undergo surgery. They must have normal kidney function or mild impairment, acceptable blood counts and liver enzymes, an ECOG performance status of 0-2 (meaning they can care for themselves), a life expectancy over 12 weeks, measurable disease by medical imaging, and a heart ejection fraction ≥45%. Men and women must use contraception; women need a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: lenvatinib plus everolimus in patients with local and metastatic renal cell carcinoma. The goal is to see if this drug combo can shrink tumors enough to make them operable when they previously weren't considered so.See study design
What are the potential side effects?
Possible side effects include high blood pressure that's hard to control even with medication; increased levels of cholesterol and triglycerides; proteinuria which means excess protein in urine indicating kidney issues; cardiovascular problems like heart failure or unstable angina.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal or nearly normal.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My kidney cancer is advanced but may be treated with surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been cancer-free from another type for less than 3 years.
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I have untreated brain metastases causing symptoms.
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I have HIV/AIDS.
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I have an active hepatitis B or C infection.
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My blood pressure is over 140/90 mm Hg, even with medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (within 14 days of day 1) and pre-surgery (week 9-10). 1) if metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (within 14 days of day 1) and pre-surgery (week 9-10). 1) if metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical complications as assessed by Clavien-Dindo classification system
Secondary outcome measures
Changes in overall response rate as assessed by RECIST 1.1
Comparison of surgical outcomes to historical controls
Treatment related adverse events as assessed by CTCAE criteria, version 4.03
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%
Pneumonia
7%
Vitamin D deficiency
7%
Ejection fraction decreased
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%
Electrocardiogram T wave inversion
3%
Electrocardiogram QT prolonged
3%
Dementia
3%
Thermal burn
3%
Blood calcium increased
3%
Varicose vein
3%
Blood creatinine increased
3%
Hypoalbuminaemia
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: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
Randomization Phase: Lenvatinib 24 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lenvatinib and Everolimus prior to cytoreductive nephrectomyExperimental Treatment3 Interventions
Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks constituting one cycle. Two cycles of treatment will be administered and after 2 weeks wash out period, the patients will go for nephrectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Lenvatinib
2020
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
Eisai Inc.Industry Sponsor
517 Previous Clinical Trials
158,921 Total Patients Enrolled
Yousef Zakharia, MDPrincipal Investigator - University of Iowa
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
4 Previous Clinical Trials
184 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your cholesterol and triglyceride levels are very high when you haven't eaten for a while.Your liver function test results (AST/ALT) are within the normal range.I have been cancer-free from another type for less than 3 years.I am not pregnant and agree to use two forms of birth control.I am a man who can father a child and agree to use birth control.Your heart's electrical activity takes too long, which can be risky.Your blood counts need to be at certain levels: white blood cells (ANC) ≥ 1.0 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8.0 g/dL.I have untreated brain metastases causing symptoms.My kidney function is normal or nearly normal.I can take care of myself and am up and about more than half of my waking hours.I have HIV/AIDS.I haven't had serious heart problems or a stroke in the last 6 months.I am 18 years old or older.I practice abstinence as my form of birth control.Your heart pumps out at least 45% of the blood with each beat.Your diabetes is not well controlled (your fasting glucose levels are too high).I have an active hepatitis B or C infection.You are expected to live for at least 12 more weeks.You have a disease that can be measured using specific criteria.My kidney cancer is advanced but may be treated with surgery.My blood pressure is over 140/90 mm Hg, even with medication.You have high levels of protein in your urine.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib and Everolimus prior to cytoreductive nephrectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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