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

July 17, 2024 updated by: Eisai Inc.

A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health, Monash Medical Centre
  • Austria
      • Klagenfurt Am Woerthersee, Austria, 9020
        • Klinikum Klagenfurt am Woerthersee
      • St. Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Austria, 1090
        • Medizinische Universität Wien (Medical University of Vienna)
    • Tirol
      • Innsbruck, Tirol, Austria
        • Universitätsklinikum Innsbruck
  • Germany
      • Berlin, Germany
        • Eisai Trial Site #2
      • Munich, Germany
        • Eisai Trial Site #6
      • Ulm, Germany
        • Eisai Trial Site #1
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany
        • Eisai Trial Site #3
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany
        • Eisai Trial Site #5
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
    • Campania
      • Napoli, Campania, Italy, 80147
        • Ospedale del Mare
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli
      • Roma, Lazio, Italy, 00133
        • Fondazione Ptv Policlinico Tor Vergata
      • Roma, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
    • Sardegna
      • Monserrato Cagliari, Sardegna, Italy, 09042
        • Azienda Ospedaliero Universitaria di Cagliari
  • Portugal
      • Coimbra, Portugal
        • Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Vila Real, Portugal, 5000-508
        • Centro Hospitalar Trás Os Montes E Alto Douro EPE
    • Setúbal
      • Almada, Setúbal, Portugal, 2805-267
        • Hospital Garcia de Orta
  • Russian Federation
    • Chuvashskaya Respublika
      • Cheboksary, Chuvashskaya Respublika, Russian Federation, 428020
        • Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia - PPDS
      • Getafe, Spain
        • Hospital Universitario de Getafe
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Málaga, Spain
        • Hospital Regional Universitario de Malaga - Hospital General
      • Santiago de Compostela, Spain, 15706
        • CHUS - H. Clinico U. de Santiago
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Corporacio Sanitaria Parc Tauli
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Murcia
      • El Palmar, Murcia, Spain
        • Hospital Universitario Virgen de La Arrixaca
  • Sweden
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset Huddinge
  • United Kingdom
      • Birmingham, United Kingdom, B15 2PR
        • University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust - Charterhouse Square
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
  • United States
    • California
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-0001
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participant with advanced or unresectable hepatocellular carcinoma.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Oral capsules.
Other Names:
  • E7080
  • Lenvima
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
Oral tablets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
Time Frame: Up to 7 years
Up to 7 years
Number of Participants With SAEs With Lenvatinib
Time Frame: Up to 7 years
Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Lenvatinib
Time Frame: Up to 7 years
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
Time Frame: Up to 7 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Lenvatinib and Sorafenib Treatment
Time Frame: Up to 7 years
Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
Time Frame: Up to 7 years
Up to 7 years
Relative Dose Intensity of Lenvatinib and Sorafenib
Time Frame: Up to 7 years
Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.
Up to 7 years
Overall Survival (OS) For Lenvatinib and Sorafenib
Time Frame: Up to 7 years
OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.
Up to 7 years
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
Time Frame: Up to 7 years
Up to 7 years
Number of Participants With Hepatotoxicity TEAEs With Sorafenib
Time Frame: Up to 7 years
Up to 7 years
Number of Participants With SAEs With Sorafenib
Time Frame: Up to 7 years
Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Sorafenib
Time Frame: Up to 7 years
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.
Up to 7 years
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib
Time Frame: Up to 7 years
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.
Up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7080-M000-508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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