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

NCT04763408 | Completed FDA Drug

• 1 other identifier: E7080-M000-508
• Study Type: observational
• Target: 335
• Locations: 9 countries
• Sites: 40

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Lenvatinib; Advanced or unresectable carcinoma hepatocellular; E7080

Outcome Measures

Primary Outcomes (4)

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

  Up to 7 years

• Number of Participants With SAEs With Lenvatinib

  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.

  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.

  Up to 7 years

Secondary Outcomes (9)

• Duration of Lenvatinib and Sorafenib Treatment

  Up to 7 years

• Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib

  Up to 7 years

• Relative Dose Intensity of Lenvatinib and Sorafenib

  Up to 7 years

• Overall Survival (OS) For Lenvatinib and Sorafenib

  Up to 7 years

• Number of Participants With Dose Interruption and Dose Reduction for Sorafenib

  Up to 7 years

Study Arms (2)

Lenvatinib

Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.

Drug: Lenvatinib

Sorafenib

Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.

Drug: Sorafenib

Interventions

Lenvatinib DRUG

Oral capsules.

Also known as: Lenvima, E7080

Lenvatinib

Sorafenib DRUG

Oral tablets.

Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participant with advanced or unresectable hepatocellular carcinoma.

You may qualify if:

• 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
• Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib

You may not qualify if:

• None

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (44)

California Liver Research Institute

Pasadena, California, 91105, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-0001, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 1871, Australia

Location

Monash Health, Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Universitätsklinikum Innsbruck

Innsbruck, Tyrol, Austria

Location

Klinikum Klagenfurt Am Woerthersee

Klagenfurt, 9020, Austria

Location

Universitätsklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, 1090, Austria

Location

Eisai Trial Site #3

Cologne, North Rhine-Westphalia, Germany

Location

Eisai Trial Site #5

Mainz, Rhineland-Palatinate, Germany

Location

Eisai Trial Site #2

Berlin, Germany

Location

Eisai Trial Site #6

Munich, Germany

Location

Eisai Trial Site #1

Ulm, Germany

Location

Ospedale del Mare

Napoli, Campania, 80147, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 00152, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

Location

Azienda Ospedaliero Universitaria Di Cagliari

Monserrato Cagliari, Sardinia, 09042, Italy

Location

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, 40138, Italy

Location

Hospital Garcia de Orta

Almada, Setúbal District, 2805-267, Portugal

Location

Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE

Coimbra, Portugal

Location

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Trás Os Montes E Alto Douro EPE

Vila Real, 5000-508, Portugal

Location

Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar

Cheboksary, Chuvashskaya Respublika, 428020, Russia

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004, Spain

Location

Hospital Universitario de Getafe

Getafe, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Location

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, 141 86, Sweden

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2PR, United Kingdom

Location

Barts Health NHS Trust - Charterhouse Square

London, EC1A 7BE, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: April 9, 2021
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); IT (6); SE (1); AU (3); DE (5); ES (13); RU (1); US (3); PT (4)