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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04763408
Registration number
NCT04763408
Ethics application status
Date submitted
17/02/2021
Date registered
21/02/2021
Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
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Scientific title
A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
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Secondary ID [1]
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E7080-M000-508
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Universal Trial Number (UTN)
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Trial acronym
STELLAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Liver
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Sorafenib
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.
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.
Treatment: Drugs: Lenvatinib
Oral capsules.
Treatment: Drugs: Sorafenib
Oral tablets.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
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Assessment method [1]
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Timepoint [1]
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Up to 7 years
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Primary outcome [2]
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Number of Participants With SAEs With Lenvatinib
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Assessment method [2]
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Timepoint [2]
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Up to 7 years
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Primary outcome [3]
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Number of Participants With Grade 3 to 5 AEs With Lenvatinib
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 7 years
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Primary outcome [4]
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Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 7 years
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Secondary outcome [1]
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Duration of Lenvatinib and Sorafenib Treatment
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Assessment method [1]
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Timepoint [1]
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Up to 7 years
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Secondary outcome [2]
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Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
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Assessment method [2]
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Timepoint [2]
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Up to 7 years
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Secondary outcome [3]
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Relative Dose Intensity of Lenvatinib and Sorafenib
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Assessment method [3]
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Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.
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Timepoint [3]
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Up to 7 years
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Secondary outcome [4]
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Overall Survival (OS) For Lenvatinib and Sorafenib
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Assessment method [4]
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OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.
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Timepoint [4]
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Up to 7 years
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Secondary outcome [5]
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Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
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Assessment method [5]
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Timepoint [5]
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Up to 7 years
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Secondary outcome [6]
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Number of Participants With Hepatotoxicity TEAEs With Sorafenib
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Assessment method [6]
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Timepoint [6]
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Up to 7 years
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Secondary outcome [7]
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Number of Participants With SAEs With Sorafenib
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Assessment method [7]
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Timepoint [7]
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Up to 7 years
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Secondary outcome [8]
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Number of Participants With Grade 3 to 5 AEs With Sorafenib
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 7 years
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Secondary outcome [9]
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Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 7 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/12/2023
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Sample size
Target
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Accrual to date
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Final
335
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Monash Health, Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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1871 - Liverpool
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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New York
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United States of America
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State/province [3]
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Texas
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Country [4]
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Austria
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State/province [4]
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Tirol
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Country [5]
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Austria
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State/province [5]
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Klagenfurt Am Woerthersee
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Country [6]
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Austria
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State/province [6]
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St. Pölten
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Country [7]
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Austria
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State/province [7]
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Vienna
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Country [8]
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Germany
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State/province [8]
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Nordrhein-Westfalen
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Country [9]
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Germany
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State/province [9]
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Rheinland-Pfalz
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Country [10]
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Germany
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State/province [10]
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Berlin
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Germany
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State/province [11]
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Munich
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Germany
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State/province [12]
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Ulm
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Italy
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State/province [13]
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Campania
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Italy
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State/province [14]
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Lazio
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Italy
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State/province [15]
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Sardegna
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Country [16]
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Italy
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State/province [16]
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Bologna
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Country [17]
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Portugal
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State/province [17]
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Setúbal
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Country [18]
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Portugal
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State/province [18]
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Coimbra
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Portugal
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State/province [19]
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Lisboa
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Portugal
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State/province [20]
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Vila Real
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Country [21]
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Russian Federation
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State/province [21]
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Chuvashskaya Respublika
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Spain
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State/province [22]
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Barcelona
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Spain
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State/province [23]
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Cantabria
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Spain
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State/province [24]
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Murcia
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Spain
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State/province [25]
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Alicante
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Country [26]
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Spain
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State/province [26]
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Córdoba
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Country [27]
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Spain
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State/province [27]
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Getafe
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Spain
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State/province [28]
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Madrid
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Spain
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State/province [29]
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Málaga
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Country [30]
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Spain
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State/province [30]
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Santiago de Compostela
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Country [31]
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Spain
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State/province [31]
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Sevilla
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Spain
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State/province [32]
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Valencia
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Spain
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State/province [33]
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Zaragoza
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Country [34]
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Sweden
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State/province [34]
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Stockholm
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Country [35]
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United Kingdom
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State/province [35]
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Birmingham
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Country [36]
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United Kingdom
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State/province [36]
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London
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Country [37]
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United Kingdom
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State/province [37]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eisai Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04763408
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04763408