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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
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
Study 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.
Select...
I am 18 years old or older.
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My kidney cancer is advanced but may be treated with surgery.
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%
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%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Oral pain
10%
Thrombocytopenia
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Hyponatraemia
7%
Ejection fraction decreased
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%
Pruritus
6%
Influenza
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Dysuria
5%
Paraesthesia
5%
Non-cardiac chest pain
5%
Productive cough
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%
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
1%
Acute coronary syndrome
1%
Blood uric acid increased
1%
Hypercalcaemia
1%
Monoparesis
1%
Death
1%
Small intestinal obstruction
1%
Intestinal obstruction
1%
Osteoarthritis
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
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%
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%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
OOL, Treatment Period: 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
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,971 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies are typically treated with Lenvatinib?
"Lenvatinib is commonly prescribed to treat transplant rejection in the liver and kidney, as well as Waldenstrom macroglobulinemia and lung conditions."
Answered by AI
What is the uppermost participant limit for this clinical trial?
"Affirmative, clinicaltrials.gov has data that this medical experiment is actively enrolling participants. It was initially posted on March 20th 2019 and the most recent update was done on May 4th 2022; it requires 15 subjects from a single centre."
Answered by AI
Are there any recorded accounts of Lenvatinib being tested on humans before?
"Currently, 232 trials are actively investigating the use of lenvatinib with 47 studies in their final phase. While Nanning, Guangxi is a major research centre for this medication, there are 8685 different sites around the world researching its efficacy and safety."
Answered by AI
Has Lenvatinib achieved regulatory acceptance from the FDA?
"The safety profile of Lenvatinib was assessed to be a 1, as this is an early phase clinical trial and hence there exists minimal evidence regarding its efficacy or safety."
Answered by AI
Has enrollment been opened for this research project yet?
"According to the information hosted on clinicaltrials.gov, this project is actively soliciting applicants. The trial was initiated March 20th 2019 and most recently updated May 4th 2022."
Answered by AI
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