Lenvatinib for Kidney Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kidney CancerLenvatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Kidney Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 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.

Week 6
Surgical complications as assessed by Clavien-Dindo classification system
Year 5
Treatment related adverse events as assessed by CTCAE criteria, version 4.03
Week 9
Changes in overall response rate as assessed by RECIST 1.1
Within two years following the last study participant's surgery
Comparison of surgical outcomes to historical controls

Trial Safety

Safety Progress

1 of 3

Side Effects for

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

Trial Design

1 Treatment Group

Lenvatinib and Everolimus prior to cytoreductive nephrectomy
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Lenvatinib · No Placebo Group · Phase 1

Lenvatinib and Everolimus prior to cytoreductive nephrectomyExperimental Group · 3 Interventions: Everolimus, Partial or Radical Cytoreductive Nephrectomy, Lenvatinib · Intervention Types: Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
161 Total Patients Enrolled
Eisai Inc.Industry Sponsor
506 Previous Clinical Trials
145,044 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
161 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient has normal renal function, as their creatinine level falls within the normal institutional limit, or their creatinine clearance is greater than 30mL/min/1.73m2, calculated using the Cockcroft-Gault formula.
The patient has a cT1b-T2a grade tumor, a cT2b grade tumor, and a cT3-cT4 grade tumor
The patient must be given written information about the study and must voluntarily agree to participate in the study.
renal cell carcinoma that is locally advanced or metastatic and has a clear cell histology, which may be considered for a partial or complete nephrectomy.
-Adjacent organs include the thyroid gland (T4), which lies just below the larynx in the neck
suggests an extremely rare entity A swollen, bulky lymphadenopathy that surrounds the renal arteries or great vessels suggests a very rare condition.
without risk factors You can have an absolute neutrophil count (ANC) of 1.0 x 109/L or higher without any risk factors.
A person's platelet count is considered high if it is at least 100 x 109/L.
The patient's AST/ALT level is below the institutional upper limit of normal.