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mTOR inhibitor
Lenvatinib + Everolimus for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable)
Adequate renal function defined as calculated creatinine clearance >=30 milliliters per minute (mL/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)
Awards & highlights
Study Summary
This trial is looking at whether a lower dose of lenvatinib, in combination with everolimus, is just as effective as a higher dose of lenvatinib with everolimus, while also being safer.
Who is the study for?
Adults with advanced clear cell renal cell carcinoma who've had one prior VEGF-targeted treatment can join this trial. They must have a measurable lesion, good performance status, controlled blood pressure, and adequate organ function. Exclusions include more than one prior VEGF treatment, active malignancy in the last 24 months, recent cancer treatments or surgeries, CNS metastases without stable recovery, uncontrolled diabetes or heart issues.Check my eligibility
What is being tested?
The study is testing two doses of lenvatinib (14 mg vs. 18 mg) combined with everolimus to see which dose has better efficacy and safety for kidney cancer patients. It's randomized and open-label; participants will be assigned by chance to receive either the lower or higher dose of lenvatinib.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, diarrhea, decreased appetite, weight loss and signs of liver dysfunction like jaundice. There may also be risks of abnormal bleeding or clotting disorders as well as potential gastrointestinal issues affecting drug absorption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is mainly clear cell type, confirmed by tissue diagnosis.
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
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My kidney cancer is in an advanced stage.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My liver tests are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)
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 at Week 24 (ORR24W)
Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks
Secondary outcome measures
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS)
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores
+7 moreSide effects data
From 2021 Phase 2 trial • 41 Patients • NCT0291578371%
Fatigue
58%
Nausea
58%
Diarrhoea
55%
Decreased appetite
52%
Vomiting
39%
Stomatitis
39%
Weight decreased
32%
Hypertension
29%
Abdominal pain
29%
Proteinuria
29%
Dyspnoea
26%
Insomnia
26%
Arthralgia
26%
Headache
26%
Epistaxis
23%
Dysphonia
23%
Anxiety
19%
Dyspepsia
19%
Cough
19%
Nasal congestion
19%
Hypothyroidism
19%
Constipation
19%
Blood creatinine increased
19%
Back pain
16%
Oedema peripheral
16%
Pain in extremity
16%
Pruritus
16%
Muscular weakness
16%
Musculoskeletal chest pain
13%
Gastrooesophageal reflux disease
13%
Dry mouth
13%
Oropharyngeal pain
13%
Anaemia
13%
Sinusitis
13%
Hypertriglyceridaemia
13%
Hypotension
13%
Hypomagnesaemia
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Toothache
13%
Oral pain
13%
Abdominal pain upper
13%
Asthenia
13%
Dizziness
13%
Dysgeusia
13%
Platelet count decreased
13%
Dehydration
13%
Hyperglycaemia
10%
Thrombocytopenia
10%
Eye swelling
10%
Pain
10%
Urinary tract infection
10%
Influenza like illness
10%
Fall
10%
Alanine aminotransferase increased
10%
Peripheral sensory neuropathy
10%
Pneumonitis
10%
Rash
10%
Productive cough
10%
Haematuria
10%
Dermatitis acneiform
10%
Peripheral swelling
10%
Depression
10%
Blood cholesterol increased
10%
Malignant neoplasm progression
10%
Sinus congestion
10%
Alopecia
10%
Blood triglycerides increased
10%
Lipase increased
6%
Non-cardiac chest pain
6%
Pneumonia
6%
Cancer pain
6%
Bone pain
6%
Abdominal discomfort
6%
Flatulence
6%
Hiccups
6%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Folliculitis
6%
Gastroenteritis viral
6%
Rib fracture
6%
Taste disorder
6%
Contusion
6%
Hyponatraemia
6%
Dry skin
6%
Acute kidney injury
6%
Skin exfoliation
6%
Swelling face
6%
Nocturia
6%
Rash maculo-papular
6%
Dysuria
6%
Pollakiuria
6%
Bronchitis
6%
Tremor
6%
Palpitations
6%
Chills
6%
Aspartate aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Hypophosphataemia
6%
Musculoskeletal pain
6%
Myalgia
6%
Urinary retention
6%
Upper-airway cough syndrome
6%
Hyperkalaemia
3%
Upper gastrointestinal haemorrhage
3%
Angina pectoris
3%
Atrial tachycardia
3%
Haematochezia
3%
Cerebrovascular accident
3%
Dry eye
3%
Lower gastrointestinal haemorrhage
3%
Pyrexia
3%
International normalised ratio increased
3%
Hepatic encephalopathy
3%
Tinnitus
3%
Pleuritic pain
3%
Abdominal distension
3%
Intestinal obstruction
3%
Hyperthyroidism
3%
Malignant ascites
3%
Sepsis
3%
Lip pain
3%
Tooth abscess
3%
Memory impairment
3%
Vision blurred
3%
Atrial fibrillation
3%
Abdominal pain lower
3%
Accidental overdose
3%
Odynophagia
3%
Skin abrasion
3%
Eye infection
3%
Respiratory syncytial virus infection
3%
Hypokalaemia
3%
Joint stiffness
3%
Nail disorder
3%
Infection
3%
Furuncle
3%
Amylase increased
3%
Aspartate aminotransferase abnormal
3%
Blood potassium decreased
3%
Blister
3%
Haemoptysis
3%
Neck pain
3%
Radicular pain
3%
Hot flush
3%
Flushing
3%
Rash macular
3%
Sciatica
3%
Hallucination
3%
Pruritus generalised
3%
Sensitive skin
3%
Vaginal discharge
3%
Bronchiectasis
3%
Pulmonary pain
3%
Hyperkeratosis
3%
Lipids increased
3%
Skin toxicity
3%
Skin ulcer
3%
Vena cava thrombosis
3%
Abdominal tenderness
3%
Cardiac failure congestive
3%
Hypoacusis
3%
Oral dysaesthesia
3%
Retching
3%
Portal vein thrombosis
3%
Ear infection
3%
Ulnar nerve palsy
3%
Confusional state
3%
Joint swelling
3%
Limb discomfort
3%
Tumour pain
3%
Balance disorder
3%
Cardiac failure
3%
Cyanosis
3%
Stress cardiomyopathy
3%
External ear pain
3%
Anal fissure
3%
Glossodynia
3%
Chest discomfort
3%
Crepitations
3%
Facial pain
3%
Blood lactate dehydrogenase increased
3%
Muscle spasms
3%
Malignant pleural effusion
3%
Melanocytic naevus
3%
Carpal tunnel syndrome
3%
Cerebral haematoma
3%
Dizziness postural
3%
Hypoaesthesia
3%
Irregular sleep wake rhythm disorder
3%
Renal pain
3%
Benign prostatic hyperplasia
3%
Respiration abnormal
3%
Respiratory tract congestion
3%
Rhinorrhoea
3%
Throat irritation
3%
Jugular vein thrombosis
3%
Cold sweat
3%
Gastrointestinal toxicity
3%
Asymptomatic bacteriuria
3%
Impetigo
3%
Injection site abscess
3%
Tooth infection
3%
Cardiac arrest
3%
Faecaloma
3%
Gastric ulcer
3%
Blood thyroid stimulating hormone decreased
3%
Blood thyroid stimulating hormone increased
3%
Blood urea increased
3%
Heart sounds abnormal
3%
Neutrophil count decreased
3%
Platelet count increased
3%
Specific gravity urine increased
3%
Vitamin D decreased
3%
Fluid retention
3%
Hypercalcaemia
3%
Hypercholesterolaemia
3%
Hypernatraemia
3%
White blood cell count decreased
3%
Hypoglycaemia
3%
Deep vein thrombosis
3%
Pleural effusion
3%
Paraesthesia
3%
Groin pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
Trial Design
2Treatment groups
Experimental Treatment
Group I: Lenvatinib 18 mg plus everolimus 5 mgExperimental Treatment2 Interventions
Participants will receive oral lenvatinib 18 mg QD plus oral everolimus 5 mg QD as the starting dose in Cycle 1 or later (cycle length =28 days) during randomization phase. After the data cutoff for the primary analysis, participants will receive study treatment as continuous 56-day cycles.
Group II: Lenvatinib 14 mg plus everolimus 5 mgExperimental Treatment2 Interventions
Participants will receive oral lenvatinib 14 mg once daily (QD) plus oral everolimus 5 mg QD as the starting dose for Cycle 1. If there are no intolerable Grade 2 or any >= Grade 3 treatment-emergent adverse events (TEAEs) that require dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), the lenvatinib dose will be escalated to 18 mg QD (plus everolimus 5 mg) beginning in Cycle 2 or later (cycle length equal to [=] 28 days) during randomization phase. After the data cutoff for the primary analysis, participants will receive study treatment as continuous 56-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lenvatinib
2018
Completed Phase 2
~270
everolimus
2005
Completed Phase 3
~1550
Find a Location
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
153,677 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,228 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What pathologies can be addressed with lenvatinib?
"Lenvatinib can be utilized to treat liver and kidney transplant rejection, as well as Waldenstrom macroglobulinemia."
Answered by AI
In what states are this clinical trial's sites located?
"This research project is being carried out at 15 different medical sites. These include Innovative Clinical Research Institute, LLC in Whittier, Baptist Health Medical Group Oncology, LLC - US Oncology in Miami and Optimal Research in Honolulu , as well as a dozen other locations."
Answered by AI
Is there currently a recruitment process for this research endeavor?
"Clinicaltrials.gov indicates that this particular trial is no longer recruiting participants, as it was initially posted on August 17th 2017 and last updated October 12th 2022. Nevertheless, there are 2818 other studies currently seeking patients to join them."
Answered by AI
What earlier studies have been made on lenvatinib and its effects?
"Presently, there are 232 studies underway assessing the efficacy of lenvatinib, with 47 active Phase 3 trials. While many of these tests occur in Nanning Guangxi, they span 8685 other locations as well."
Answered by AI
What has been the regulatory agency's ruling on lenvatinib?
"We appraise lenvatinib as a 2 on the safety scale due to its designation as a Phase 2 trial, thus indicating that there is some data attesting to its security but nothing regarding efficacy."
Answered by AI
What is the ultimate goal of this clinical experiment?
"The principal objective of this trial, measured at Week 24, is to discover the percentage of participants with intolerable Grade 2 or any Grade greater than or equal to Grade 3 toxic effects. Additionally, Progression-free Survival (PFS), Objective Response Rate (ORR) and Number of Participants With TEAEs and Serious TEAEs are secondary outcomes. PFS is calculated by measuring time from randomization till either progression documented through investigator assessment as per RECIST v1.1 criteria or decease; ORR is assessed based on Best Overall Response (BOR) according to RECIST v1.1 after completion of treatment; last"
Answered by AI
How many individuals are enrolled in this experiment?
"Unfortunately, this trial is not currently accepting candidates. It was initially published on August 17th 2017 with the latest edit made on October 12th 2022. Should you be interested in other medical trials, there are 2586 active studies for carcinoma and 232 open clinical trials for lenvatinib."
Answered by AI
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