A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

Eisai Inc.335 enrolled

Overview

The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[SAEs\], grade 3 to 5 adverse events \[AEs\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.

Study Type

OBSERVATIONAL

Enrollment

335

Conditions

Carcinoma, Hepatocellular

Interventions

LenvatinibDRUG

Oral capsules.

SorafenibDRUG

Oral tablets.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label 2. Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib Exclusion Criteria: None

Locations (44)

Outcomes

Primary Outcomes

Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib

Time frame: Up to 7 years

Number of Participants With SAEs With Lenvatinib

Time frame: Up to 7 years

Number of Participants With Grade 3 to 5 AEs With Lenvatinib

AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.

Time frame: Up to 7 years

Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib

Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information.

Time frame: Up to 7 years

Secondary Outcomes

Duration of Lenvatinib and Sorafenib Treatment

Time frame: Up to 7 years

Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib

Time frame: Up to 7 years

Relative Dose Intensity of Lenvatinib and Sorafenib

Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.

Data from ClinicalTrials.gov

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California Liver Research Institute

Pasadena, California, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Monash Health, Monash Medical Centre

Clayton, Victoria, Australia

Universitätsklinikum Innsbruck

Innsbruck, Tyrol, Austria

Klinikum Klagenfurt Am Woerthersee

Klagenfurt, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, Austria

...and 34 more locations

Time frame: Up to 7 years

Overall Survival (OS) For Lenvatinib and Sorafenib

OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.

Time frame: Up to 7 years

Number of Participants With Dose Interruption and Dose Reduction for Sorafenib

Time frame: Up to 7 years

Number of Participants With Hepatotoxicity TEAEs With Sorafenib

Time frame: Up to 7 years

Number of Participants With SAEs With Sorafenib

Time frame: Up to 7 years

Number of Participants With Grade 3 to 5 AEs With Sorafenib

AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with sorafenib. AEs will be graded using NCI CTCAE. Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.

Time frame: Up to 7 years

Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib

Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib will be collected at the discretion of the treating physician and in accordance with the prescribing information.

Time frame: Up to 7 years