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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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%

Abdominal pain upper

18%

Pain in extremity

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%

Hypoalbuminaemia

10%

Thrombocytopenia

10%

Oral pain

10%

Blood creatinine increased

10%

Electrocardiogram QT prolonged

10%

Upper respiratory tract infection

Dehydration

Neck pain

Hypomagnesaemia

Depression

Influenza like illness

Muscle spasms

Lymphopenia

Alanine aminotransferase increased

Muscular weakness

Malaise

Haematuria

Ejection fraction decreased

Pruritus

Hyponatraemia

Blood thyroid stimulating hormone increased

Platelet count decreased

Aspartate aminotransferase increased

Toothache

Glossodynia

Blood alkaline phosphatase increased

Hyperkeratosis

Bronchitis

Flatulence

Influenza

Dysuria

Anxiety

Hyperglycaemia

Leukopenia

Non-cardiac chest pain

Productive cough

Paraesthesia

Hypothyroidism

Haemoptysis

White blood cell count decreased

Pneumonia

General physical health deterioration

Malignant pleural effusion

Sepsis

Cholecystitis

Pulmonary embolism

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Spinal cord compression

Acute kidney injury

Blood uric acid increased

Intracranial tumour haemorrhage

Acute respiratory failure

Small intestinal obstruction

Monoparesis

Hepatic failure

Acute coronary syndrome

Appendicitis

Hypercalcaemia

Death

Respiratory failure

Osteoarthritis

Intestinal obstruction

Colitis

Transient ischaemic attack

Pancreatitis

Atrial flutter

Cardio-respiratory arrest

Uterine prolapse

Coronary artery stenosis

Pneumatosis intestinalis

Cerebrovascular accident

Confusional state

Liver injury

Diverticulitis

Bacteraemia

Gastroenteritis

Perineal abscess

Wound infection

Malignant neoplasm progression

Bone pain

Cancer pain

Syncope

Vocal cord paralysis

Nephrotic syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Randomization Phase: Lenvatinib 24 mg

Randomization Phase: Placebo

OOL, Treatment Period: Lenvatinib 24 mg

OOL, Treatment Period: Lenvatinib 20 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2070

0 / 17Eligibility criteria met