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Completed

NCT Number: NCT04763408

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

None

Treatment and study plan

Lenvatinib

Drug

Oral capsules.

Other names: Lenvima, E7080

Sorafenib

Drug

Oral tablets.

Primary outcomes

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

    Time frame: Up to 7 years

  2. Number of Participants With SAEs With Lenvatinib

    Time frame: Up to 7 years

  3. 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.

  4. 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.

Secondary outcomes

  1. Duration of Lenvatinib and Sorafenib Treatment

    Time frame: Up to 7 years

  2. Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib

    Time frame: Up to 7 years

  3. 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.

  4. 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.

  5. Number of Participants With Dose Interruption and Dose Reduction for Sorafenib

    Time frame: Up to 7 years

  6. Number of Participants With Hepatotoxicity TEAEs With Sorafenib

    Time frame: Up to 7 years

  7. Number of Participants With SAEs With Sorafenib

    Time frame: Up to 7 years

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

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

Acronym: STELLAR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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