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

Carcinoma, Hepatocellular Clinical Trial

— STELLAR  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04763408
• Other study ID #: E7080-M000-508
• Status: Active, not recruiting
• Start date: April 9, 2021
• Est. completion date: March 7, 2031

Study information

• Verified date: March 2024
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: March 7, 2031
• Est. primary completion date: March 7, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Lenvatinib
Oral capsules.
• Sorafenib
Oral tablets.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Health, Monash Medical Centre	Clayton	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Austria	Universitätsklinikum Innsbruck	Innsbruck	Tirol
Austria	Klinikum Klagenfurt Am Woerthersee	Klagenfurt Am Woerthersee
Austria	Universitätsklinikum St. Pölten	St. Pölten
Austria	Medizinische Universitat Wien (Medical University of Vienna)	Vienna
Germany	Eisai Trial Site #2	Berlin
Germany	Eisai Trial Site #3	Köln	Nordrhein-Westfalen
Germany	Eisai Trial Site #5	Mainz	Rheinland-Pfalz
Germany	Eisai Trial Site #6	Munich
Germany	Eisai Trial Site #1	Ulm
Italy	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi	Bologna
Italy	Azienda Ospedaliero Universitaria Di Cagliari	Monserrato Cagliari	Sardegna
Italy	Ospedale del Mare	Napoli	Campania
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Italy	Fondazione Policlinico Universitario A Gemelli	Roma	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata	Roma	Lazio
Portugal	Hospital Garcia de Orta	Almada	Setúbal
Portugal	Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE	Coimbra
Portugal	Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar Trás Os Montes E Alto Douro EPE	Vila Real
Russian Federation	Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar	Cheboksary	Chuvashskaya Respublika
Spain	Hospital General Universitario de Alicante	Alicante
Spain	C.H. Regional Reina Sofia - PPDS	Córdoba
Spain	Hospital Universitario Virgen de La Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario de Getafe	Getafe
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Regional Universitario de Malaga - Hospital General	Málaga
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	CHUS - H. Clinico U. de Santiago	Santiago de Compostela
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Barts Health NHS Trust - Charterhouse Square	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United States	Montefiore Medical Center	Bronx	New York
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	California Liver Research Institute	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Germany,  Italy,  Portugal,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib		Up to 7 years
Primary	Number of Participants With SAEs With Lenvatinib		Up to 7 years
Primary	Number of Participants With Grade 3 to 5 AEs With Lenvatinib	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
Primary	Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib	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	Duration of Lenvatinib and Sorafenib Treatment		Up to 7 years
Secondary	Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib		Up to 7 years
Secondary	Relative Dose Intensity of Lenvatinib and Sorafenib	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
Secondary	Overall Survival (OS) For Lenvatinib and Sorafenib	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
Secondary	Number of Participants With Dose Interruption and Dose Reduction for Sorafenib		Up to 7 years
Secondary	Number of Participants With Hepatotoxicity TEAEs With Sorafenib		Up to 7 years
Secondary	Number of Participants With SAEs With Sorafenib		Up to 7 years
Secondary	Number of Participants With Grade 3 to 5 AEs With Sorafenib	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
Secondary	Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib	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