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Tyrosine Kinase Inhibitor

Lenvatinib for Recurrent Liver Cancer Post-Transplant

Q: Could you please summarize any prior research projects involving Lenvatinib?

The first clinical trial studying lenvatinib took place in 2016 at Call for Information (Investigational Site 0002). Subsequently, there have been 624 completed studies. Currently, 148 active trials are underway with a considerable amount of these located near Atlanta, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.

Q: Are there any opportunities for participation in this research endeavor?

The clinical trial is actively accepting participants, as indicated on the official webpage. This research was initially published in April 19th 2022 and its information has been recently updated in June 16th of the same year.

Q: What possible risks are associated with Lenvatinib usage?

Lenvatinib's safety has been assessed, with a score of 2. This is due to the drug being in Phase 2 trials, where there are data regarding its safeguard but no reports verifying its efficacy yet.

Q: Is this trial the inaugural endeavor of its type?

Since its first clinical trial in 2016 sponsored by Merck Sharp &#x26; Dohme Corp., Lenvatinib has seen massive development. After Phase 1 approval, the drug is now a part of 148 live trials spanning 1017 cities and 53 countries worldwide.

Q: How many participants have signed up for this investigation?

Affirmative. According to information hosted on clinicaltrials.gov, this study is recruiting as of now. It was first posted on April 19th 2022 and last modified on June 16th 2022; researchers are searching for 19 volunteers distributed between 2 medical sites.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

My liver function is mildly affected.

Select...

I had a liver transplant to try to cure my condition.

Select...

I agree to use effective birth control during and for 60 days after the study.

Select...

I am 18 years old or older.

Select...

My kidney function, measured by creatinine or its clearance, is within the required range.

Select...

I am mostly self-sufficient and can carry out daily activities.

Select...

My liver cancer has returned after a liver transplant and cannot be removed with surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

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%

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

Dehydration

Neck pain

Hypomagnesaemia

Influenza like illness

Muscle spasms

Depression

Lymphopenia

Alanine aminotransferase increased

Muscular weakness

Hyponatraemia

Ejection fraction decreased

Haematuria

Malaise

Blood thyroid stimulating hormone increased

Platelet count decreased

Aspartate aminotransferase increased

Toothache

Glossodynia

Blood alkaline phosphatase increased

Hyperkeratosis

Bronchitis

Pruritus

Influenza

Anxiety

Flatulence

Hyperglycaemia

Leukopenia

Dysuria

Productive cough

Non-cardiac chest pain

Paraesthesia

Hypothyroidism

Haemoptysis

White blood cell count decreased

Pneumonia

General physical health deterioration

Cholecystitis

Sepsis

Pulmonary embolism

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Malignant pleural effusion

Spinal cord compression

Acute kidney injury

Acute coronary syndrome

Blood uric acid increased

Hypercalcaemia

Monoparesis

Death

Small intestinal obstruction

Intestinal obstruction

Osteoarthritis

Colitis

Transient ischaemic attack

Acute respiratory failure

Pancreatitis

Atrial flutter

Cardio-respiratory arrest

Uterine prolapse

Coronary artery stenosis

Pneumatosis intestinalis

Cerebrovascular accident

Confusional state

Hepatic failure

Liver injury

Diverticulitis

Appendicitis

Bacteraemia

Gastroenteritis

Perineal abscess

Wound infection

Intracranial tumour haemorrhage

Malignant neoplasm progression

Bone pain

Cancer pain

Syncope

Vocal cord paralysis

Respiratory failure

Nephrotic syndrome

100%

80%

60%

40%

20%

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: 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

2005

Completed Phase 4

~2690

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,677 Total Patients Enrolled

4 Trials studying Liver Cancer

468 Patients Enrolled for Liver Cancer

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,835 Total Patients Enrolled

104 Trials studying Liver Cancer

26,668 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please summarize any prior research projects involving Lenvatinib?

"The first clinical trial studying lenvatinib took place in 2016 at Call for Information (Investigational Site 0002). Subsequently, there have been 624 completed studies. Currently, 148 active trials are underway with a considerable amount of these located near Atlanta, Georgia."

Answered by AI

Are there any opportunities for participation in this research endeavor?

"The clinical trial is actively accepting participants, as indicated on the official webpage. This research was initially published in April 19th 2022 and its information has been recently updated in June 16th of the same year."

Answered by AI

What possible risks are associated with Lenvatinib usage?

"Lenvatinib's safety has been assessed, with a score of 2. This is due to the drug being in Phase 2 trials, where there are data regarding its safeguard but no reports verifying its efficacy yet."

Answered by AI

Is this trial the inaugural endeavor of its type?

"Since its first clinical trial in 2016 sponsored by Merck Sharp & Dohme Corp., Lenvatinib has seen massive development. After Phase 1 approval, the drug is now a part of 148 live trials spanning 1017 cities and 53 countries worldwide."

Answered by AI

How many participants have signed up for this investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, this study is recruiting as of now. It was first posted on April 19th 2022 and last modified on June 16th 2022; researchers are searching for 19 volunteers distributed between 2 medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant

Olumide Gbolahan 2022. "Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05103904.

All > Liver Transplant > Hepatocellular Carcinoma