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

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ClinicalTrials.gov Identifier: NCT04763408
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Lenvatinib Drug: Sorafenib

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : March 31, 2028
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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:
  • Lenvima
  • E7080
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participant with advanced or unresectable hepatocellular carcinoma.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763408


Contacts
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Contact: Eisai Medical Information 1-888-274-2378 esi_oncmedinfo@eisai.com

Locations
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Sponsors and Collaborators
Eisai Inc.
More Information
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT04763408    
Other Study ID Numbers: E7080-M000-508
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
Lenvatinib
Advanced or unresectable carcinoma hepatocellular
E7080
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Sorafenib
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action