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Tyrosine Kinase Inhibitor

Lenvatinib for Recurrent Liver Cancer Post-Transplant

Phase 2
Recruiting
Led By Mehmet Akce
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days of cycle 1 day 1; after at least 7 days without growth factor support or transfusion)
Child Pugh class A
Must not have
Significant cardiovascular impairment: history of congestive heart failure greater than NYHA class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening
Females who are breastfeeding or pregnant at screening or baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing lenvatinib to see if it can help people with HCC that has come back after a liver transplant.

Who is the study for?
Adults with recurrent hepatocellular carcinoma after liver transplant, who are in good physical condition (ECOG <=1), have measurable disease, and a life expectancy over 12 weeks. They must not be planning surgery, have brain metastases or uncontrolled illnesses like heart failure. Participants need normal organ function tests and agree to use contraception.
What is being tested?
The trial is testing Lenvatinib's effectiveness for patients whose liver cancer has returned post-transplant. It aims to block enzymes that tumor cells need to grow since there's no established treatment for this recurrence.
What are the potential side effects?
Lenvatinib may cause high blood pressure, fatigue, loss of appetite, weight loss, nausea, vomiting, stomach pain or upset stomach; it can also affect how your thyroid gland works.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My white blood cell count is healthy without recent medical help.
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My liver function is mildly affected.
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I had a liver transplant to try to cure my condition.
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I agree to use effective birth control during and for 60 days after the study.
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I am 18 years old or older.
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My kidney function, measured by creatinine or its clearance, is within the required range.
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I am mostly self-sufficient and can carry out daily activities.
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My liver cancer has returned after a liver transplant and cannot be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart problems like recent heart attacks or severe heart failure.
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I am currently pregnant or breastfeeding.
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My blood pressure is not controlled even with medication.
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I have been treated with lenvatinib or another FDA-approved drug for liver cancer after a transplant.
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I don't have bleeding disorders or a high risk of severe bleeding.
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I haven't had treatment for another cancer type, except skin or treated cervical cancer, in the last 2 years.
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I do not have brain metastases.
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My urine protein levels are low based on a 24-hour test.
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I haven't had radiotherapy in the last 4 weeks and have no lasting side effects from previous treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Duration of response (DR)
Overall survival (OS)
Progression-free survival (PFS)

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%
Dysgeusia
18%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Dyspepsia
15%
Hypocalcaemia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Thrombocytopenia
10%
Hypoalbuminaemia
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Depression
8%
Influenza like illness
8%
Muscle spasms
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Haematuria
7%
Malaise
7%
Pruritus
7%
Ejection fraction decreased
7%
Hyponatraemia
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
6%
Flatulence
6%
Dysuria
6%
Influenza
6%
Anxiety
6%
Hyperglycaemia
6%
Leukopenia
5%
Productive cough
5%
Non-cardiac chest pain
5%
Paraesthesia
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Cholecystitis
2%
Malignant pleural effusion
2%
Sepsis
2%
Pulmonary embolism
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Spinal cord compression
2%
Acute kidney injury
1%
Hypercalcaemia
1%
Respiratory failure
1%
Appendicitis
1%
Acute respiratory failure
1%
Intracranial tumour haemorrhage
1%
Acute coronary syndrome
1%
Death
1%
Hepatic failure
1%
Osteoarthritis
1%
Blood uric acid increased
1%
Intestinal obstruction
1%
Monoparesis
1%
Small intestinal obstruction
1%
Colitis
1%
Transient ischaemic attack
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%
Liver injury
1%
Diverticulitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Nephrotic 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)Experimental Treatment2 Interventions
Patients receive lenvatinib PO QD. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the protocol therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2017
Completed Phase 4
~2040

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,647 Total Patients Enrolled
4 Trials studying Liver Cancer
468 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,981 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 Patients Enrolled for Liver Cancer
Eisai Co., Ltd.Industry Sponsor
178 Previous Clinical Trials
660,306 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05103904 — Phase 2
Liver Cancer Research Study Groups: Treatment (Lenvatinib)
Liver Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT05103904 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103904 — Phase 2
~1 spots leftby Nov 2024
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