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.
Brief Title
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
Categories
Completion Date
Completion Date Type
Actual
Conditions
Carcinoma, Hepatocellular
Eligibility 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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
Lenvatinib
Advanced or unresectable carcinoma hepatocellular
E7080
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04763408
Org Class
Industry
Org Full Name
Eisai Inc.
Org Study Id
E7080-M000-508
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Measure
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants With SAEs With Lenvatinib
Outcome Time Frame
Up to 7 years
Outcome Description
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.
Outcome Measure
Number of Participants With Grade 3 to 5 AEs With Lenvatinib
Outcome Time Frame
Up to 7 years
Outcome Description
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.
Outcome Measure
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib
Outcome Time Frame
Up to 7 years
Secondary Outcomes
Outcome Time Frame
Up to 7 years
Outcome Measure
Duration of Lenvatinib and Sorafenib Treatment
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib
Outcome Description
Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.
Outcome Time Frame
Up to 7 years
Outcome Measure
Relative Dose Intensity of Lenvatinib and Sorafenib
Outcome Description
OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.
Outcome Time Frame
Up to 7 years
Outcome Measure
Overall Survival (OS) For Lenvatinib and Sorafenib
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants With Hepatotoxicity TEAEs With Sorafenib
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants With SAEs With Sorafenib
Outcome Description
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.
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants With Grade 3 to 5 AEs With Sorafenib
Outcome Description
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.
Outcome Time Frame
Up to 7 years
Outcome Measure
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Participant with advanced or unresectable hepatocellular carcinoma.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andreas Kaubisch
Investigator Email
akaubisc@montefiore.org
Investigator Phone
718-920-7100
Categories Mesh Debug
Endocrine System Cancers --- ADENOCARCINOMA
Cancer --- CARCINOMA
Lung & Chest Cancers --- NEOPLASMS, GLANDULAR AND EPITHELIAL
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- LIVER DISEASES
Liver --- LIVER DISEASES
MeSH Terms
CARCINOMA, HEPATOCELLULAR
ADENOCARCINOMA
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
LIVER NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
DIGESTIVE SYSTEM DISEASES
LIVER DISEASES
LENVATINIB
SORAFENIB
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